'Full Measure': Fighting for her life
WASHINGTON (Sinclair Broadcast Group) - "Full Measure" has learned the FDA is planning a public meeting as it grapples with a little-known but serious risk from a common medical procedure: MRIs. The danger comes from an injected chemical agent - a heavy metal called gadolinium used to enhance the images. Doctors used to think it was quickly expelled from the body.
It turns out that's not always the case and it makes a small percentage of people very sick, as it did the wife of American icon Chuck Norris.
Gena Norris: "I just heard that still, small voice deep inside of me that said, 'Gena your body is dying.' And I walked out of the bathroom and he just took one look at me and he knew; I'm about to lose my wife."
Sharyl Attkisson: "You took one look at her; what did you see?"
Chuck: "Well, I saw death in her eyes. I saw her dying and I said, 'You know, I've got to do something.'"
For Chuck and his wife, the nightmare began when Gena had three MRIs in one week to evaluate her rheumatoid arthritis. The MRIs triggered a cascade of mysterious health issues that nearly killed her.
Gena: "I was in the emergency room for like five or six nights in a row and the symptoms had continued to get worse and worse. And by the fourth, fifth, sixth night, the burning just kept traveling and I would go in and they'd say, 'Well, what's wrong with you?' And I'm like 'I, I don't know. I don't feel good. And I'm just, I'm burning. I, that's all I can tell you is I'm burning all over. I feel like I have acid everywhere in my tissues, I'm just, I'm on fire.'"
Doctors tested her for everything from cancer to ALS, Parkinson’s and multiple sclerosis, but were mystified. Gena began a desperate search and turned up published literature and patient accounts pointing to one thing: poisoning from a substance injected into her before the MRI. It contains a toxic heavy metal called gadolinium.
Gena: "When we got to the hospital in Houston this last time, and I'm so bad and I said, 'Listen, I am sober enough in my thinking right now,' because I had such brain issues going on, I said, 'I'm only going to be able to tell you this one time and I need you to listen to me very closely. I have been poisoned with gadolinium or by gadolinium and we don't have much time to figure out how to get this out of my body or I am going to die.'"
Chuck: "I can take her anywhere in the world, I'm blessed enough to have the money to do that, but where do I take her?"
The answer was alternative medicine in China and before that, a clinic in Reno, Nevada where Gena received intensive treatment for gadolinium poisoning and slowly came back to life.
Chuck: "Well, the thing is, is when we got there, she couldn't swallow. And so they were having to feed her baby food just to be able to get food down her, her esophagus."
Gena: "There were so many other problems, you know that I was having, by then my arm is completely drawn up like this. I mean, I laid in a bed in that clinic for five months on IVs, every day and my wonderful, wonderful, wonderful, wonderful husband, who I'm so thankful, thank you, baby, laid on a couch next to me for five months and read. How many books?"
Chuck: "Seventeen books."
Gena: "He read, but he didn't leave me and we were away from our children. They were still, our youngest, we have seven kids and our youngest are twins and they were about 11 at the time. And as I'm lying in the bed, I'm just saying over and over again, 'I'm going to live to raise my kids. I'm going to live to raise my babies.'"
Her treatment revealed that the gadolinium, which was supposed to be gone from her body hours after each MRI, had remained in astonishing levels that were literally off the charts.
Gena: "This is in the danger zone and you will see that I stayed at the level for a very, very long time."
Gadolinium-based contrast agents, often referred to as “dye,” are injected in patients in about a third of 60 million MRIs per year. It can provide better images for some diagnoses such as brain cancer. Doctors long insisted it’s quickly expelled from the body through the kidneys.
But internal FDA documents show that more than a decade ago, scientists understood that wasn’t always the case. Starting in early 2006, they recognized a “strong association between gadolinium contrast agents and NSF,” nephrogenic systemic fibrosis, a deadly disease that causes thickening and tightening of skin and organs.
In 2007, the FDA added a serious “black box” warning. It said the only patients at risk were those with weak kidneys who were unable to eliminate the gadolinium.
The problem is, a lot of people getting very sick didn’t have kidney issues. Gena was one of them.
Gena: "I had been asking from the beginning if it could have had anything to do with the scans that I had done and they said it was impossible for it to be related to that, and so I just kind of put it in the back of my mind and I'm ..."
Attkisson: "But that's when everything started?"
Gena: "It made perfect sense that it was somehow related and they just, either, again, out of maybe ignorance, I know that's a strong word, or they just don't want to admit it because they don't know how to treat it or it would open up a whole big can of worms. They just didn't want to go there."
Sharon Williams: "I didn’t have bad kidneys. I had normal renal function. So, it shouldn’t have affected me."
Williams had five MRIs with gadolinium over several years and got sicker each time.
Attkisson: "So, the sicker you became and the more pain that you have, the more MRIs that you got."
Attkisson: "Which gave you more doses of this chemical?"
Williams: "Yes, yes and a lot of people I talked to that is a similar story with people who had multiple MRIs. So, my symptoms got dramatically worse after dose four. We thought there had to be something wrong with my brain, so I had dose five for a brain MRI. And literally all hell broke loose after that. I mean, it was terrible."
Attkisson: "Meaning what?"
Williams: "Meaning that’s when all the symptoms went crazy. I mean, I couldn’t begin to tell you how severe some of the symptoms were as far as pain, spasms, problems with my blood pressure - very, very high blood pressure."
Doctors tested her for everything from scleroderma to autoimmune disorders.
Attkisson: "Can you take me through the process. How did you figure out it was this gadolinium?"
Williams: "When I wasn’t going to the doctor I was doing research. Extensive research. I often would go 18 hours, 20 hours a day."
She says she identified the gadolinium as the source of her problem even before tests found the heavy metal in her body.
Williams: "In 2014, I had part of my thyroid gland removed and gadolinium was in it 51 months after my last MRI. It shouldn’t be there. Supposed to get rid of it right away."
In 2015, for the first time, the FDA issued an alert about gadolinium lingering in patients without kidney problems, like Gena and Sharon, but downplayed any risks.
FDA video: "Recent studies conducted in people and animals have confirmed that gadolinium can remain in the brain, even in individuals with normal kidney function. Available information does not identify any adverse health effects."
Williams says the FDA has dragged its feet for too long on what’s a known danger for some patients.
Williams: "I have a whole lot of thickened tissue all across my abdomen, up in my upper legs, things going on, obviously in my face and that, definitely in my brain."
She had five MRIs with gadolinium contrast agents and got sicker after each one.
Starting in 2012, she began sending the FDA all the research she’d found showing the possible health risks of gadolinium. Over the years, the FDA repeatedly told her it was investigating.
Absent better insight from the FDA, she helped start a support group and now counsels other patients.
Williams: "Well, it makes no sense because what’s going on with us is caused by gadolinium."
The FDA wouldn’t agree to an interview but told us it “believes no clinical effects have been identified due to gadolinium in the brain,” and it’s evaluating rare reports of “chronic pain and various other symptoms” to determine if “there are any potential adverse health effects.”
Gena nearly died in 2013 after three MRIs in a row with gadolinium injections. Tests showed incredible levels of gadolinium remained in her body. She eventually sought non-traditional treatments for gadolinium poisoning.
After six months at a clinic in Reno, Gena was well enough to go home to Texas, but far from healed.
Chuck: "Everyone that takes gadolinium is not going to get sick. It's ones that are sensitive like Gena. You know me, I didn't, you know I've taken them and I've never gotten sick. But that doesn't mean that we shouldn't do something about the other people that are getting sick from the gadolinium."
Dallas toxicologist Dr. Alfred Johnson helped direct Gena’s ongoing treatment.
Johnson: "Is it different batches of gadolinium that aren't made correctly or there's some problem with it, or is it a problem with that individual's metabolic, genetic aspect that they don't tolerate it very well? Regardless, what I've seen in the patients that I've treated is high levels of gadolinium in their tissues."
Attkisson: "How many patients have you treated with this problem?"
Johnson: "I've treated probably four or five patients. Uh, not many, but they have really chronic problems that doctors really haven’t paid too much attention to."
Gena says getting better has meant everything from seeing specialists in China to getting oxygen therapy in a hyperbaric chamber. They even bought one to have it close by.
Gena: "In this machine alone, I’ve done probably about 100 dives, we call them dives, just to help heal my brain."
Last March in Europe, a government health committee made a striking recommendation to suspend use of several gadolinium-based contrast agents.
That includes the biggest sellers made by GE and Bayer. They, too, declined our interview requests but told us: patient safety is a top priority and they don’t believe gadolinium is causing “clinical symptoms or adverse events.” GE has asked European health officials to reconsider the recommended ban.
Both companies and the FDA told us “the risk benefit profile [for gadolinium products] remains favorable.”
Gena: "I mean, the person that you see right now is the person that I was before I got sick. And we're talking now after all of these years. I mean we're talking many, many years to even get to where I am today."
Today, Gena connects with others who have what they believe is gadolinium-induced illnesses after MRIs. Most can’t afford the non-traditional doctors and treatments that insurance won’t pay for, but made her better.
The Norrises shared their tax records showing medical expenses of $821,000 in 2013, $1.18 million in 2014 and $293,000 in 2015.
Gena: "We've been blessed enough to be able to afford the alternative or the integrative treatments and modalities and the medicines that are out there. There are millions of people that, that don't have that, OK, and because insurance doesn't pay. So, that is an issue in and of itself. And we have spent well over a million dollars, if not more, to save my life."
Attkisson: "Any final thoughts you have just watching your wife go through this experience?"
Chuck: "Well, it's the helpless feeling, you know, 'cause I'm kind of a take charge guy, and then here I have something where I, I, I cannot do anything and it was, it was horrifying and, and, uh, I just thank, thank God that we were able to weather it and that she did get better and I got my wife back."
GE and Bayer have admitted no fault but confidentially settled hundreds of lawsuits involving their gadolinium contrast agents. In 2015, the FDA approved the first gadolinium MRI contrast agent for infants and babies under age 2.