It’s possible you haven’t heard that my wife, Gena, and I are suing 11 Big Pharma companies. We don’t need the money. It’s a crime we’re trying to stop. It’s for Gena and all people who have suffered, are currently suffering and will suffer through gadolinium poisoning administered during routine MRIs.
Our hope and goal is to continue raising awareness about the dangers of gadolinium retention in the body while educating patients – present and future – about the lack of warnings currently in place for gadolinium-based contrast agents, or GBCAs.
In short, like thousands or even millions of you who have gone through an MRI with contrast dye that was injected into your body to make images clearer, Gena had three scans within eight days about five years ago to assess for rheumatoid arthritis.
Those multiple MRIs yielded little about her arthritis, but they did give her gadolinium poisoning and Gadolinium Deposition Disease, which nearly took her life, resulting in unbelievable pain and anguish, multiple hospitalizations and two years of traveling the globe to look for a remedy and relief.
As my wife has clearly expressed, while MRIs are necessary, safe contrasting agents need to be developed or new-generation MRI machines designed that don’t require any use of contrast.
What’s crazy is that, despite countless people suffering through Gadolinium Deposition Disease, the U.S. Food and Drug Administration, or FDA, has still not approved the most common gadolinium removal treatment, chelation. Patients must seek out and pay for chelation themselves because insurance companies won’t pay for what is considered alternative treatment, and the FDA fails to recognize chelation as an effective treatment. Heartbreakingly, countless people are suffering or may even die as a result.
And most of all, the FDA continues to downplay adverse effects and refuses to confess to the greater public that it’s even a problem, even after requiring hospitals, clinics and health-care professionals around the country to post new warning labels on GBCAs. (The FDA sent out its hazard memo over Christmas break, likely to remain off the radar to the public and news.)
Despite the FDA’s whitewashing, we are pleased to hear and read how other health and medical publications and news sites are sounding the MRI gadolinium alarm, such as:
The European Medicine’s Agency, or EMA, has stopped the use of linear GBCAs that don’t shield patients from the admittedly toxic metal – gadolinium, with the United Kingdom’s national health authority suspending the use of two products.
And look who else has joined the anti-gadolinium movement by taking the right steps to protect its country’s citizens: Japan! The Japanese Ministry of Health, Labor and Welfare, or MHLW, has decided to restrict the use of non-specific linear GBCAs so that they are used only in cases where there is no alternative, based on the “higher Gadolinium accumulation in brain reported with these linear agents.”
Yet, the FDA continues to hold its stubborn grounds by not taking the reasonable steps and precautions as Europe, the U.K. and Japan. Why? Because millions of U.S. citizens have already been injected with GBCAs, and the agency and Big Pharma fear the greatest legal whiplash in history.
In order to stop the injections in the U.S. from crippling one more patient, we are asking our legal team to pursue the 11 Big Pharma companies that produced and distributed the drug to Gena and her doctors. We are represented by attorneys Todd Walburg and Brooks Cutter of Cutter Law in California. The law firm filed the first Gadolinium Deposition Disease lawsuit in 2016.
In response to the litigation, some in the mainstream media like CBS rushed to back the FDA, saying things like, “The U.S. Food and Drug Administration said in May it found no evidence that retained gadolinium was harmful.” But they are not telling you the whole story.
As “Full Measure” reported, internal scientific documents from the FDA that are over a decade old reveal the agency has known about the potential adverse affects of GBCAs for a long time, but it did little to warn the general public.
In his article, “Chuck Norris, FDA and Gadolinium – Untangling the Lawsuit,” Dr. Charles Dinerstein, M.D., M.B.A., F.A.C.S., a retired vascular surgeon and senior medical fellow at the American Council on Science and Health, summarized the progressive downfall and dangers of linear GBCAs.
Over the years, Dr. Deinerstein explained: “[T]here was increasing evidence that the chelating compounds [used alongside gadolinium injections in hope to protect patients from its toxicities] were not as effective as was anticipated. A 1998 study showed that 25% of the gadolinium was not recovered in patient’s urine; a 2005 survey found gadolinium in some patients’ bones and a 2014 study showed continued presence of gadolinium in patient’s brain tissue. The hallmark study, Gadolinium in Humans: A Family of Disorders, was published in 2016 in the American Journal of Radiology. It describes a spectrum of conditions characterized by retention of gadolinium, from asymptomatic patients (Gadolinium Storage Condition) to symptomatic patients (Gadolinium Deposition Disease) to patients with NSF.”
That is what led Dr. Sidney Wolfe, who has made Modern Healthcare/Modern Physician’s 50 Most Influential Physician Executive List four times, to say, “It’s just a matter of time before the metals deposited in the brain turn into disease.”
That is why Dr. Allan Spreen, M.D., NorthStar Nutritionals’ chief research adviser, says the GBCA injections should be “adamantly refused.”
More and more doctors, scientists and other health-care professionals are coming forward to discuss the dangers of residual GBCAs. Many more whistleblowers have trumpeted across the country and around the world, but they have been muffled by the health-care professional status quo culture of dodge and deny, but no more!
That is why in September of 2017, the FDA was forced to meet and announce that it will require additional warnings for GBCAs to alert patients to gadolinium retention in the human body, including in organs, bones and the brain. Unfortunately, the warnings will be only on labels of the drug, and most patients will never see them!
To add insult to injury, Big Pharma producers of GBCAs have recently washed their hands of culpability by saying they are not responsible for patients’ ignorance or avoidance of heeding hazardous gadolinium warnings. But how can patients dodge gadolinium retention warnings if they never receive them? Doesn’t Big Pharma bear some responsibility in producing a drug that can be hurting millions of people every year and not sufficiently warning about it?
Big Pharma companies are hoping that you and others remain ignorant and inactive in stopping this problem. They are predicting that the contrast agent supply and demand is going to explode sales globally through 2025 and make peddlers of the products – like Bayer, GE, Bracco, Guerbet and McKesson – more money than ever.
Friends and fellow Americans, we must blow the trumpet of truth and voice our concerns today to the FDA, the World Health Organization and every medical community, including your local ones, because it’s possible they don’t know and are continuing “business as usual.”
Please join our growing army, take the following steps, and sign the petition HERE:
- Share this column – and others I’ll write on the issue – on your social media.
- Friend us at our Facebook page, MRI Gadolinium Contrast Awareness group.
- Encourage others to watch Gena and my “Full Measure” interview.
- Warn physicians and patients about the risks of gadolinium. Make sure physicians are properly informing patients about its dangers.
- Suspend the use of all Linear GBCA and restrict Macrocyclic GBCAs to much smaller and infrequent doses and use them only in cases where the benefits far outweigh the risks, like in matters of life and death or the most serious of health issues.
- Invest in rapid development of new-generation MRI machines that don’t require contrast dyes, or at least use safe alternatives to gadolinium.
- Sponsor large, independent studies of gadolinium toxicity in patients who have undergone MRI scans.
- Fast-track the development and approval of effective treatments to remove toxic gadolinium from patients affected by it.
- Fast-track regulations requiring insurance companies to cover the costs of new effective treatments for gadolinium poisoning, NSF, Gadolinium Deposition Disease and Gadolinium Storage Condition.
As Medscape.com recommends, report any problems with GBCAs by contacting MedWatch, the FDA’s safety information and adverse event reporting program, via telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online, with postage-paid FDA form 3500 or by mail to: MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
To read my column about the FDA gadolinium hearing in September 2017 and hear the insider debate on the issue, see “Is the FDA ready to jump in the ring with me?”
For more information on gadolinium toxicity, go to MRI Gadolinium Contrast Awareness group. Also, visit this site to learn more. And stay tuned to hear more real gadolinium news and updates from Gena and me.