World Renowned Toxicologist on Gadolinium Intoxication
Yesterday in news that shocked even the MRI/Gadolinium Toxicity Awareness Campaign, the FDA made a statement about Gadolinium that acknowledged the widespread retention of this toxic heavy metal.
To quote from the US FDA announcement on May 22, 2017: 'Some human and animal studies looked at GBCA use over periods longer than a year. These publications and reports show that GADOLINIUM IS RETAINED IN ORGANS SUCH AS THE BRAIN, BONES, and SKIN. The publications show that linear GBCAs retain more gadolinium in the brain than macrocyclic GBCAs...'
They fell short of acknowledging the significance of the retention, but are still reviewing. This is a huge step, however, and seemingly definitive.
The next piece of the puzzle is understanding the significance of the retention- this is something that they are still looking at, to truly believe one may have fatal NSF or no ill effects of retention seems far fetched. It's important therefore to consult and take advice from leading world experts. We now have an acknowledged widespread toxicology issue to face per their statement so it's important now we learn more from the worlds leading toxicologists, the issue is now within that universe given Gadolinium is toxic. Here we have the findings, conclusions and suggestions to verify alongside the FDAs HUGE acknowledgement of wide spread Gadolinium intoxication the impact that Gadolinium intoxication has on a human being... please read.. the puzzle is now complete... we have widespread retention and now we know can understand the potential ramifications.
Dr P.J.VanDerSchaar, MD. PhD. FCMT truly is one of the worlds most decorated and remarkable Doctors. A former globally renowned heart surgeon who in the 1970s was instrumental in moving the world forward in the treatment of heart surgery and patient care.
Later on his career he moved into Toxicology and once again found huge acclaim. He spent 30 years with the International Board of Clinical Metal Toxicology where he served as President until recently. He continues to write the seminal Clinical Metal Toxicology Textbook which is studied by toxicologists world wide as part of the examination process. He is also noted with bringing chelation therapy and advancing toxicology in India.
Dr P.J.VanDerSchaar continues to practice toxicology to this day and remains at the forefront. He has treated patients with Gadolinium intoxication and continues to do so, alongside Dr Hickey in the US he is a world leader in this. His voice in toxicology remains the worlds most respected.
Here is his knowledge, conclusions and suggestions on this matter of Gadolinium.
Gadolinium Toxicity Gd3+
Gadolinium chelates are widely used as contrast media for magnetic resonance imaging. The approved gadolinium-based contrast agents (GBCAs) have historically been considered safe and well tolerated when used at recommended dosing levels.
Magnetic resonance imaging
Magnetic resonance imaging (MRI) is a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body in both health and disease. MRI scanners use strong magnetic fields, radio waves, and field gradients to generate images of the organs in the body.
MRI does not involve x-rays, distinguishing it from computed tomography (CT or CAT). MRI can often yield different diagnostic information compared with a CT.
Magnetic resonance imaging (MRI) with gadolinium-based contrast agents (GBCAs) have been used for more than 25 years in more than 100 million patients.
The extraordinarily positive recorded safety record of GBCAs with serious adverse reactions only in the range of 0.03% of all administrations has made possible research studies in humans to focus on pathologically relevant changes in the blood-brain barrier permeability.
However, heavy metals such as gadolinium are also highly toxic to mammals and humans, and has precluded using free Gd3+ as a human contrast agent. Several Food and Drug Administration (FDA) approved Gd3+ bound to a chelating molecule that renders GBCAs sufficiently safe for acute intravenous use in humans while preserving gadolinium’s paramagnetic activity for MRI detection. Critical to the safety of any GBCAs is for free Gd3+ to remain tightly bound to its chelating agent as long as it remains in the patient’s body. With normal kidney function the biological half-life of GBCAs for CNS indications is between 90–120 min, which eliminates significant dissociation of Gd3+ from its chelating agent resulting in barely detectable release and accumulation of free toxic Gd3+ in the body fluids and tissues.
This is in contrast to what we have found in our studies.
The use of gadolinium has been and should continue to be guided by the risk-benefit ratio. However it is important we reassess the risk given we are learning much more about retention as testing is coming online. Last month the FDA launched an investigation on the risk of brain deposits following a repeated use of GBCAs (http://www.fda.gov/Drugs/DrugSafety/ucm455386.htm)
Previously it was widely believed that GBCAs are rapidly and completely excreted from the human body in an intact state. In recent years, however, there is a growing body of data that demonstrates that gadolinium accumulates in tissues, including brain, bone, and kidneys, of patients exposed to GBCAs during magnetic resonance imaging (MRI) despite normal renal function. Retention of gadolinium increases in those who have repeated GBCA exposure. Patient initiated survey results available through the Lighthouse Project (a patient advocacy group) and various growing Facebook groups of injured patients show the onset of a series of symptoms, including neurological, musculoskeletal, and dermal, within a month of an MRI. The understanding and testing of the mechanisms of gadolinium toxicity can help determine the clinical significance of gadolinium retention in tissues so that the risks of GBCA use for MRIs can be better assessed. This can then serve to develop guidelines for GBCA use, the development of new gadolinium chelates with higher stability and less toxicity, and determining the utility of gadolinium chelation therapy.
Notwithstanding that Gadolium coupled to a chelator has an impressive safety record, lately we have to recognise that Gadolinium injections may cause Gadolinium intoxication and retention.
Doctors need to know about this disease by periodic medical literature or by notification issued by the Department of National Health and have availability to test for it.
Gadolinium intoxication is a debilitating disease. These patients are chronically ill, in constant pain, cannot mentally perform their job and have lost their zest of living. The social impact is not negligible and must be understood.
There are no fast and sufficient treatments for this problem, but the chelator DTPA is at this time the best therapy for a number of complaints. It is an inexpensive easily obtainable medication and must be made widely available.
These patients need to counsel what treatment options they have and where they can be treated, but Gadolinium intoxication poses serious health risks and must not be ignored.
A patient needs to tested before the actual Gadolinium injection with the MRI. Such a test needs to be developed,but should analyse existing gadolinium and other heavy metal amounts as well as check the functionality of major organs.
Doctors are cautioned to avoid using it with patients who have acute kidney injury or performance issues or are at high risk of nephrogenic systemic fibrosis.
A provocation test for all patients who have had an MRI with gadolinium injection within the last 6 months will be conducted to conclude if there are differences between patients with and without intoxication.
An investigation is needed to understand the brands of Gadoliniums used at hospitals.
This should include analysis of the hospitals with the highest number of Gadolinium intoxications. Testing for Gadolinium intoxication and developing the best treatment options is most vital.
Dr P.J.VanDerSchaar, MD. PhD. FCMT