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American Board of Magnetic Resonance Safety (ABMRS)
MRI safety recently took a step forward with the formation of the American Board of Magnetic Resonance Safety (ABMRS). According to its website, the not-for-profit corporation’s purpose is to improve the safety of medical and research magnetic resonance (MR) environments. That includes the safety of MR facilities and the certification and qualification of the professionals who oversee the physical and operational safety of the MR equipment, environment, and processes.
The leadership of the founding Board of Directors includes the following:
- Chair: Emanuel Kanal, MD, Director of MR Services at the University of Pittsburgh Medical Center
- Vice Chair: Max Amurao, Phd, Director of Radiation Safety for Clinical Programs at Columbia University/New York Presbyterian Hospitals
- Secretary/Treasure: Tobias Gilk, MArch, Sr. Vice President of Radiology-Planning and Founder of Gilk Radiology Consulting
Is history repeating itself? Are Gadolinium-Based Contrast Agents the next Thorotrast?
While doing research in early 2012, I came across a 2007 article written by J.F.M. Wetzels of The Netherlands that really caused me to pause and think about the problems associated with Gadolinium-Based Contrast Agents. The title was “Thorotrast toxicity: the safety of Gadolinium compounds”. Thorotrast was a radiocontrast agent used from 1930 to 1960. It wasn’t until the late 1940’s that the first “Thorotrast-related malignancies” were described in the literature and the problem came to light.
Thorotrast particles had been deposited in cells in the liver, spleen, bone marrow, and lymph nodes where they stayed and continually exposed the surrounding tissue to radiation. The problems created by Thorotrast had such a long-latency period that malignancies might not show up for 45 years or more later.
Wetzels described what was happening with Gadolinium and NSF through 2006. He said that because Gadolinium is a toxic, heavy metal, “Gadolinium-Based Contrast Agents are all chelates, which must ensure that no free Gadolinium is present in the circulation”. Wetzels closed by saying, “we must keep in mind that toxic effects may occur less frequently, later, and only after repeated exposure in patients with less severe renal dysfunction”. When I read that, I thought of what might be happening to patients with normal renal function. (more…)
We have an important advocate in Dr. Manny Kanal.
After years of trying to get the FDA and medical community’s attention about the issue of Gadolinium retention in patients with normal kidney function, it looks like our efforts have begun to pay off.
I want to share some news about Dr. Emanuel (Manny) Kanal. If you aren’t familiar with his name, Dr. Kanal is a leading radiologist and someone the FDA looks to for advice on matters related to MRI Safety. Duke and I have been in communication with him since October of 2013.
As you might imagine, MRI Safety is an important issue that requires medical professionals to stay well-informed about safety issues directly related to MR devices as well as the Gadolinium-based Contrast Agents administered for contrast-enhanced MRI and MRA. Since June of this year, Dr. Kanal has been conducting MRI Safety Officer (MRSO) and MRI Medical Director (MRMD) Seminars.
During a seminar on September 9, 2014, Dr. Kanal provided a “Gadolinium Contrast Overview”. According to the MRI Patient Safety blog, besides describing the state of NSF, he described “new and growing concerns about non-NSF bio-retention”. (more…)
Iceberg ahead!
So why am I talking about an iceberg on the Gadolinium Toxicity website? Let me explain.
Not long after I started researching NSF and Gadolinium in early 2010, I saw a reference to an editorial by Dr. Henrik Thomsen of Denmark that had been published in 2008. The title was, Is NSF Only the Tip of the “Gadolinium Toxicity” Iceberg? The title caught my attention and really made me think. It took me a while, but I finally managed to find the editorial. After reading it, I had more questions than answers.
It seems that in the early 1990s, there was already concern about the stability of the nonionic linear GBCAs, and the macrocyclic agents were found to be significantly more stable in serum. It was known that transmetallation with other metal ions in the body was more apt to occur with the DTPA-based chelates, and when transmetallation occurs it results in the toxic Gadolinium ion remaining in the body. Dr. Thomsen asked, “Why were nonionic linear chelates chosen instead of macrocyclic chelate?” That is a very good question.
For those of us in the U.S., a better question might be, why did it take the FDA longer to react than the European Medicines Agency (EMEA) and the Japanese authorities? (more…)
Gadolinium Toxicity 