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FDA Acts to Restrict GE’s Omniscan MRI Drug, and Two Others

In a setback for GE Healthcare, the U.S. Food and Drug Administration has announced new labeling requirements that ban use of the contrast agent Omniscan and two other drugs in patients with severe kidney disease, who could be at risk of a crippling and fatal disease.

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Jeff Immelt, chairman and CEO of GE, during a presentation on General Electric's strategy for global health in May, 2009. (Saul Loeb/AFP/Getty Images)

Sept. 10: This post has been updated.

The U.S. Food and Drug Administration said today that GE Healthcare’s Omniscan and two other MRI drugs should not be used in patients with severely impaired kidneys because they risk developing a rare but potentially fatal disease.

The decision marks a turnabout for the FDA and brings U.S. labeling requirements for Omniscan and the other drugs more in line with those in Europe, where an association first surfaced between Omniscan and the disease, nephrogenic systemic fibrosis, or NSF.

It also comes as a setback to GE Healthcare, which argued against special FDA labeling for Omniscan, and which faces hundreds of lawsuits from patients who contracted NSF.

ProPublica reported last year on GE Healthcare’s efforts to defend Omniscan, and on the company’s attempt to muzzle a Danish radiologist who criticized the drug.

Magnevist, the market leader, sold by Bayer HealthCare, and Optimark, which is sold by Covidien, are also affected by the FDA’s announcement Thursday.

Covidien last year acted on its own to contraindicate use of Optimark for at-risk kidney patients. But GE and Bayer continued to assert that their drugs were no riskier than the other so-called contrast agents, which are used to make MRIs easier to read.

The FDA has approved seven such drugs for use in the United States.

GE Healthcare and Bayer issued statements Thursday emphasizing their continued concern about patient safety and pointing out that tens of millions of doses have been used as diagnostic tools without any adverse effects.

GE said it would update Omniscan’s label to reflect that the drug should not be administered to patients with severe kidney damage. Bayer said it would respond to the FDA’s action within 30 days.

The first link between contrast agents containing gadolinium, a heavy metal, and NSF, a crippling condition with potentially lethal complications, surfaced in 2006. The next year, the FDA recommended a “black box” warning for at-risk kidney patients.

The agency decided to treat all the drugs as a class, ignoring two of its own medical reviewers, who said Omniscan was associated with a disproportionately high share of NSF cases and wanted to ban its use in patients with severe kidney conditions.

Since 2007, all contrast drugs sold in the U.S. have carried the same warning on their labels. Regulators in Europe, by comparison, acted that year to contraindicate use of Omniscan, Magnevist and Optimark in patients with severe kidney disease.

Amid continuing concerns about safety last year, the FDA convened two advisory panels in December to look at the issue again. The agency’s scientists had done further research and concluded that warning labels for the three drugs should be made sterner.

The panels recommended a ban on Optimark and Omniscan. But while some panel members also voiced concerns about Magnevist, there was a wide range of opinions about what to do and no consensus.

The FDA normally follows the recommendations of its advisory panels.

More than 110 million doses of Magnevist have been sold worldwide, according to Bayer; GE Healthcare says Omniscan, the nearest competitor, has been used more than 48 million times.

All the manufacturers deny that their drug causes NSF. Omniscan has been linked to more of the reported cases of the disease than any other drug and has been named in more lawsuits than the other drug companies.

Since the disclosure of the disease the market share of Omniscan has fallen by about one half and the percentage of a less risky drug, MultiHance, made by Bracco Diagnostics, has risen, according to FDA data presented last December.

In addition to banning the three drugs for some, the FDA urged better screening to discover at-risk patients before using any of the gadolinium-based agents, which are administered intravenously, and closer monitoring of patients for signs of NSF afterward.

NSF has not been reported in patients with healthy kidneys, the FDA said. The disease, marked by scaling, hardening and tightening of the skin, or red or dark patches, can also cause fibrosis of internal organs that may lead to death, the FDA said.

New reports of NSF have virtually disappeared thanks to heightened awareness about the condition.

Update: Covidien has issued a statement in response to the FDA's action.

I’ve had two MRI’s last year and two this year. While my kidney’s so far have been healthy this concerns me greatly.

Lyris,

The MRI scan, itself, is of no threat to you regarding NSF development. You could have had an MRI per day for a year, and that would produce no known long-term health effects.

It is only the contrast agent that presents the risk, and then only if you have significantly impaired renal function, and then its only a very small risk if you have one of the least stable GBCAs administered to you.

I’ve had several of these and I do not have kidney disease but I am sick, very sick.  There is something they are not telling us about these contrasting agents. 

It’s logical to assume that if these injections are bad for kidney patients they are bad for everyone especially if gadolinium leaks into the bodies of those with healthy kidneys as it did in a comparison of Omniscan and Prohance. Some information from the stude follows.

Comparison of Gd DTPA-BMA (Omniscan) versus Gd HP-DO3A (ProHance) Retention in Human Bone Tissue by Inductively Coupled Plasma Atomic Emission Spectroscopy Wendell A. Gibby, MD,* Krissa A. Gibby,† and W. Andrew Gibby‡

“Conclusion: Omniscan (Gd DTPA-BMA) left 2.5 times more Gd
behind in bone than did ProHance (Gd HP-DO3A).”

Sharon,

Gadolinium is a nasty, toxic heavy-metal. They wouldn’t inject it into people if the Gadolinium, itself, wasn’t tightly locked to another molecule that prevented it from coming loose and bonding with your tissues.

Each of the Gadolinium Based Contrast Agents is ‘locked’ to a different molecule (chelate), and for some of them the lock is sturdier than others. Omniscan has the weakest ‘lock’ of the currently-approved US GBCAs. Over a period of time, a small proportion of the weakly-locked Gadolinium can dissociate from the chelate.

If you have healthy kidneys, your body has already cleaned all of the GBCA from your bloodstream before this can happen. If your kidneys are less efficient, they may still do the study but use one of the more tightly-locked GBCA compounds.

So it takes two factors… the ‘weakness’ of the chelate bond *and* the time it’s in your system (a product of kidney function).

Snickers bars may be very dangerous to diabetics, but the logic that they’re dangerous to one population doesn’t necessarily hold true when tested against other (non-diabetic) populations.

We shall see.  I have many of the symptoms of NSF without the kidney disease.  Most of the GBCAs I had WAS Omniscan and although I am not in medicine I do have intuition on my side and I believe this stuff has leaked into my body and I know I’m sick from it. 

Let me ask you this.  Has GE checked the patients without kidney disease days, weeks, months and years after receiving Omniscan to ensure that it is not leaking into the bodies of healthy patients?

Sharon,

To your question about testing patients without renal problems… I don’t know if this has been done since 2006 when NSF came to light. The drug approval process would have necessitated significant testing prior to approval by the FDA, so at least something must have been done (but whether the studies were set up to find the factors that are believed relevant to NSF, I couldn’t say, either).

Snickers bars may be very dangerous to diabetics but if you’re a diabetic and you eat a Snickers bar you know the risk.  I didn’t know the risk and was given Omniscan several times.  If it leaked into my body and gave me this dreadful disease that is a huge problem for me and many like me that are sick and can’t get the help we need because legal and medical decided you had to have kidney disease or else you can’t have this disease. 

I hope others will come forward and tell their stories about how gadolinium based contrasting agents changed their lives. 

And here’s another IMPORTANT point.  The disease that has presented itself from gadolinium - a toxic-heavy-metal, NSF can teach us a lot about what heavy metals do to us once they are in the body.  Instead medicine has decided to ignore it and shove it under the rug so that they can go on and inject everyone with toxic-heavy-metals and get away with destroying the lives of millions more like me that are sick but can’t get a diagnosis because we don’t have kidney disease.

Tobias Gilk

“Gadolinium is a nasty, toxic heavy-metal. They wouldn’t inject it into people if the Gadolinium, itself, wasn’t tightly locked to another molecule that prevented it from coming loose and bonding with your tissues.”

So you agree if they find gadolinium in the tissue days, months, weeks or years after it means that they are most likely suffering from gadolinium poisoning?

Sharon,

You’re correct that the lay person should not be expected to know the risk profile of each medication their doctors administer (that should be their job). There were such a small number of NSF cases that it, as a condition, was virtually unknown until a few years ago. As such, many doctors, including radiologists, didn’t know the risk factors.

There is a definitive test to see if one has NSF. You can get a skin biopsy to test for the presence of Gadolinium. If you have questions about your exposure to GBCA, you can ask your doctor for the test.

It is my understanding that the presence of gadolinium in the tissue does not a NSF diagnosis make. 

And if they don’t test for gadolinium in the tissue it is astounding.  How absurd it that?  We all know that if you are carrying around toxic levels of gadolinium you have been poisoned with a toxic-heavy-metal. 

Those that have a vested interest in these scans want us to believe that these contrasting agents, especially the ones that leak into the body like Omniscan are not indicative of disease.  That they are somehow benign and don’t cause disease.  This is because a huge amount of money is at stake and the manufacturers’ profits will decline should it be common knowledge that they are leaking into the bodies of healthy people as well as those with kidney disease.  It’s an industry that has billions of dollars at stake.

I applaud the FDA for doing what they are doing but in my opinion they do not go far enough.  I think these products warrant a closer look don’t you?

Sharon,

Hundreds of millions of doses of GBCAs have been administered over the last few decades.  According to the article, 48 million doses of Omniscan have been administered.  Yet, there has not been a single reported case of NSF among people with normal renal function.

Let’s put this in perspective.  Suppose Omniscan did cause NSF at a ridiculously low rate of 1 in a million administrations.  Suppose further that half the cases fell through the cracks without being detected.  There should still be a few dozen reports of NSF in people with normal renal function.  Where are those patients?

Full disclosure:  I am a pediatric radiologist who prescribes GBCAs to children on a daily basis with appropriate restrictions for those with renal disease.  Should evidence of NSF show up in patients other than those with renal dysfunction, we would adjust our practice accordingly.

Thank you for your response.  I’m not sure I understand why there is such a low rate of NSF but I’m glad there is.  My concern is that many others are being harmed with a different disease than NSF that is also debilitating but doesn’t involve renal failure. 

If you find that Omniscan and the few others mentioned in this article are leaving gadolinium behind in the bodies of those without kidney impairment would you still administer those doses even though these patients show no short term symptoms? What do you make of the study/comparison that I posted earlier? 

As a pediatric radiologist you must be concerned if gadolinium is showing up in the tissue of your patients long after it should have been chelated out of their bodies.  Have you ever checked?

“Hundreds of millions of doses of GBCAs have been administered over the last few decades.  According to the article, 48 million doses of Omniscan have been administered.  Yet, there has not been a single reported case of NSF among people with normal renal function.”

I believe this is because they have excluded anyone that does not have kidney disease from getting the diagnosis.  In other words no kidney disease no diagnosis. 

If these contrasting agents are leaving behind gadolinium in the bodies of those lucky enough to get their heath insurance companies to pay for an MRI there are scientific evidence that supports the assertion that gadolinium is toxic.  Do you agree with this?

If you are convinced that Omniscan and the two other contrasting agents mentioned in the article are not causing any problems or are not leaving behind toxic levels of gadolinium do a retrospective review of the tissue you have done biopsies of in the past. And let’s take a child that is having weakness and stiffness in their limbs and pain in their joints.  And let’s take a child that has had more than two of these MRIs with contrast with Omniscan and look to see if there is any gadolinium in the tissue.

The problem with ICP-AES is that it does not tell you whether the detected Gd is free or chelated.  In your study, they assumed that the Gd they detected was free.  Is that a safe assumption???  The answer matters because Gd toxicity is associated with free Gd, but not chelated Gd.

Suppose that it is free Gd that they detected.  Then the question becomes, what is the clinical significance of the concentration difference that they showed?  Is this concentration difference associated with any symptom or disease?

It is not our practice to biopsy asymptomatic children in order to look for Gd in their skin after a contrast-enhanced MRI.  We do, however, adhere to ACR guidelines for contrast administration and keep abreast of developments in this area (such as the FDA decision reported in this article.)

Neal

Neal

I was not suggesting you biopsy asymptomatic children.  I am suggesting you look at tissue that has already been collected for other reasons/diagnosis and check that tissue for gadolinium.  The permission of the parents would be needed of course but they would likely agree because they want answers as well.  It’s clear to me this will never happen as there is too much money to be made from keeping this a mystery.

Sharon,

I think you may be painting the medical industry with an overly-broad brush. Yes, I’m sure that GE would not be excited about the prospect of finding entire new populations of patients with Gadolinium adverse reactions, but they don’t set the course for the profession.

There are nephrologists and radiologists around the world focused on this issue, who ‘connected the dots’ of a relatively small number of patients (globally) and hunted for similarities until the Gadolinium link was found. These doctors and researchers ‘discovered’ the disease, deduced the cause, and - in a manner of a couple years - virtually eliminated all new occurrences of it.

And if the professional diligence of the medical community didn’t uncover hidden incidences of the disease, you can’t run a Google search on ‘Gadolinium’ without a number of paid ads from plaintiffs attorneys seeking out persons with NSF to represent in the lawsuit. It’s only about 3 or 4 today, but a year ago it was more like 10. You don’t think they have an interest in finding more confirmed cases of GBCA toxicity?

I don’t believe that anyone has eliminated a patient from possible diagnosis of NSF because they didn’t have impaired renal function. Reduced renal function is not a symptom of NSF, it is strongly believed to be a contributing cause. In fact, I’m anecdotally aware of a NSF case which threw the whole kidney function element into question a couple years ago.

A young patient with no history of poor renal function developed NSF after an MRI. It was later discovered, after having been held up as disproof of the renal function link, that the patient had been given the MRI for an injury in which the patient had suffered (among other injuries) a temporary acute kidney injury.

To my knowledge, every biopsy-confirmed case of NSF correlates directly to either a chronic or acute renal function issue, whether or not that renal function issue had been appropriately diagnosed prior to the MRI.

Assuming that NSF can only occur in someone with renal failure and that gadolinium can only leak into the body if you are in renal failure what is the harm in looking back at prior biopsies that were done post MRIs with Omniscan and seeing if gadolinium is present in that tissue.  I ask you as someone that is knowledgeable in the field if this has been done and if not why not? 

As a consumer I am not convinced that deposits of gadolinium in our bodies are safe. I’d like to know based on scientific evidence that gadolinium is not leaking into the bodies and staying there for years after an MRI.

Sharon,

The Gadolinium doesn’t really ‘leak’ into your body… it is typically injected straight into a vein. It’s swimming around - bound to a chelate - in your bloodstream and starts being filtered out as soon as it is circulated through your kidneys. It takes a few hours to get the GBCA concentration down to near zero (this is true for all but one of the GBCAs, which is removed by the liver). The GBCA is collected by the kidney, deposited in the bladder, and you pee it out.

NSF is believed to be the product of some of the Gd breaking free of its chelate, and seeking other mates. Gd is a very ‘needy’ element and will bond with other elements in your body quite readily.

If the chelate bond (my ‘lock’ in a prior post) isn’t broken (and the different GBCA agents have significantly different strength ‘locks’), then even slow kidneys will cleanse it from your body, though over a longer time period.

To your question about whether or not widespread retrospective skin biopsies have been (should be) done post-GBCA administration, I’m not aware of any. As there is always the potential for an adverse outcome from any procedure, even a skin biopsy, generally there has to be a defined anticipated benefit that warrants the risk. I’m under the impression that the current clinical thinking is that compromised renal function is a fundamental causative element in the development of NSF. Without that precursor, testing patients with healthy kidney function would expose them to risk without a perceived benefit.

I think you miss my point.  Upon autopsy gadolinium was found in multiple organs and tissues in a patient that died of NSF after exposure to gadolinium through an MRI or MRA I don’t’ remember which.

I’m not saying biopsy anyone.  I’m saying the FDA should do a retrospective review of biopsies already done.  There has to be literally millions of these out there, tissue samples where the patient had a biopsy after an MRI or MRA.  Look at biopsies that showed no disease.  Please don’t obfuscate what I am saying.  I not saying do biopsies of anyone in the present.  I am saying let’s take a retrospective review as I mentioned in my prior post. 

Has this been done and if not why not?

dead_man_walking

Sep. 12, 2010, 6:21 p.m.

Sharon
Your instincts are correct. NSF can & does exist in patients that had no diagnosis of renal impairment before exposure to gadolinium contrast. I am a documented case and can tell you,,,it has been a living hell dealing with the medical community.
I’m not sure how much they will allow me to post on this forum, but I’m well known,,,even by the FDA.
Type the following phrase into a google browser without the brackets: [the train radiologist didn’t see coming]. That can be a starting point for you to read my nightmare as what you are currently expereincing. I am the author of articles that has that phrase in the subject line un-broken, on the 1st & 2nd page of “hit’s” received on that google search.
Please spare yourself, Mr. Radiologist, I’ve got allot of official info than just the article I found disussing the Bayer Executive/co-inventor of magnivest gadolinium contrast admitting & proving that the industry had known there were problems with the gadolinium contrast since the 1980’s. [GAO audits of the FDA post drug marketing adverse event disvisions],,,google it. The FDA is dysfunctional to say the least. The pathology community and this renal impairment requirement before a histology of NSF can be determined,,,,,,bull,,,,,don’t even get me started.
The industry can adminster a gazillion doses of gadolinium contrast an allege anything,,,,,drug post marketing adverse events (say like nsf) are solely voluntary in this and most all other countries. Barely 10% is ever reported to the FDA,,,,,,got sources,,,it is in the best interest (the trial bar lawyers that you love so much) of the healthcare provider to NOT report adverse events related to gadolinium contrast,,,,& they are not mandated by law to do so. I have two clinical diagnosis of NSF/histology of NSF and gadolinium was detected in my skin. I was NOT a renal patient of any kind before this known toxic unstable formulated heavy metal was injected into my body.

Lets try the above for starters,,,,,,I’m also known by the top nsf researchers/physicians in this country and Denmark. Your not alone Sharon,,, perform the 1st google search, read the documented links/articles, link up via that route.

dead_man_walking thank you for your post.  I am very discouraged but I haven’t given up.  I intend to become very active until I die with this disease. I intend on reading all of the articles you recommend.  I will not give up and like you I plan on telling everyone I can how toxic this stuff is.

dead_man_walking

Sep. 12, 2010, 11:38 p.m.

Sharon,
Great to hear that you have begun the search for the truth. The medical community will attempt every game in the book to prevent you from documenting NSF in a non-renal impaired diagnosed pateint. But, it can be done. Omniscan contrast is bad news.
Seek out (google it) physicians in your region that are known specialist in NSF, most will be nephroglogist. I found mine by simply emailing images of the fibrosing of my legs to the specialist in my region. Another tactic the industry is utilizing against any non-renal impaired case of gad/NSF,,,,,,morally weak pathologist. If you can get the clinical diagnosis of NSF/NFD and decide to allow a deep tissue biopsy,,,,be sure the biopsy is taken from within a region that is showing the skin fibrosis. As you will read,,,,I’ve been through hell with the histology part. 1st biopsy was taken outside the fibrosing region of my leg (tissue that appeared normal) intentionally to cause a disconnect with the clinical diagnosis of NSF, they still found disease at the deep dermal layers. But, it caused me to have to obtain a 2nd biopsy, this time from the oldest fibroid region of my leg,,,,,,that one stuck.

Be aware that if you do in fact have NSF, any further tissue trauma will acclerate the disease. Discuss with/request that the physician providing the NSF diagnosis to NOT include any patient history with the tissue biopsy to the pathology lab to be analyzed via histology for NSF. That is where enormous bias is taking place,,,,,,,most of the pathology community cannot tell the difference between NSF & Scleroderma or similar skin/vascular disorders (NSF histology is still evolving). If the pathologist knows your medcial history (non-renal impairment diagnosis) they will default to a biased histology of anything but NSF/NFD. It’s a proven fact and should a legal issue, it will, if I have any say about it. They are playing with peoples lives.
There are some within the medical/legal community that believes that NSF can be diagnosed in full without a further tissue trauma (biopsy).
Another point,,,,you as a patient can file your own FDA adverse event with the gadolinium contrast. But, based on your current health status, if possible,  I would at least obtain a clinical diagnosis of NSF first, then file it or have (seek out) counsel to file it for you. Obtain copies of your medical records from the facility(s) that performed the gadolinium contrast studies as soon as possible,,they are usually free,,,,that is another object/record/tactic that seems to get lost/mis-filed/etc.

Transmetallation - that is a term for what is “releasing” (leaking) the known highly toxic free gadolinium (Gd3) into patients bodies allowing for tissue deposition,,,,,then the fibrosing-disease is triggered.

In my expereinced opinion stay away from the Yale NSF site/nsf yahoo support group/nsf registery/global fibrosis foundation sponsored through Yale University,,,,,other than reading NSF information/links,,,,,they are another pro-corporate sponsored diversionary site/entity that is not acting in favor of “all” - (non-renal) nsf patients,,,,but are acting in their corporate/financial interest in trying to minimize the collateral damage of the MDL 1909 litigation by trying desperately to keep this disease solely within the renal impaired patient community. I’ve had the same lines listed in the above post to you,,,,fed to me so many times by the “experts”, it isn’t funny anymore,,,though they boast that they are for the patient,,,most are NOT when it comes to the gadolinium/NSF subject.
I have in excess of 2.2 GB of research on this subject (20,000+ pages of medical/clinical/scientific articles solely discussing gadolinium & NSF).
Seek me-others-counsel out,,,,I/others will try to help you in every we can. It is impossible for me to provide complete advice from all my set-backs/irritations in a couple post. Just don’t give up,,,,,keep seeking,,,,,,you are not alone.

dead_man_walking

I agree with what you are saying as I have already been through some of what you have written.  I am trying to reach out to you via email but haven’t been able to find an address. 

I’m not asking you to reveal your email here but know that I am looking through the sites you recommended. 

I hope others will come forward with their stories. It’s sad to know that children are being injected with this stuff as well but they are adding insult to injury by not telling us why we are sick.

dead_woman_talking

Sep. 13, 2010, 8:29 p.m.

dead_man_walking it’s Sharon here.  I decided to change my name to reflect how I feel. 

I went to some of the sites you recommended and I am so grateful for your help.  I did get a virus from one of them and I’m in the process of cleaning my other laptop.  I have several so this is a minor inconvenience.

But the information you provided was worth an infected computer as I now have more support and backup to look at and decide on a plan of action.  I personally have notified eight doctors and around 70 people.  I’ve done this by warning them of the dangers of gadolinium injections.  If we can get 50 more people to spread the word and those 50 people each get 50 more people we may be able to get the word out. And that word is you do not have to have chronic kidney disease to get NSF.  It can be one acute incident and because this disease is so new it could be that many others will present with it at a later time.  It is known that “even in persons with normal renal function, a small amount of the Gd from GBMCA is apparently released into the body”.  And this could have huge implications for our society as this disease is estimated to cost over a million dollars per incident of disease.

The dollars involved here could easily surpass $1T and it is understandable why radiologists and the manufacturers don’t want it to be revealed that pretty much anyone can get this disease if exposed to gadolinium.

dead_man_walking

Sep. 14, 2010, 8:15 a.m.

Yes, it is big and it runs very, very deep into the pro-corporate society that we currently live. One of the parties involved (GE) own’s at least one major news outlet and control an unknown number of corporate entities.
Attempts to spread the word has been tried by many, but money continues to suppress thier voices. Visit K-frds forum again, private message path, it is one that has not moderated/deleted my attempts to spread the word. All others/trolls need not apply, I will expose you publicly every time.
The research proves that NO person (healthy or not) has ever excreted 100% of the bolus dose of gadolinium contrast.
Some researchers have voiced thier concern of gadolinium build-up/retention within the patient population. PubMed.com is another excellent source for information. Search [Nephrogenic systemic fibrosis, gadolinium contrast, gadodiamide, nephrogenic fibrosing dermopathy, Omniscan, Magnivest, Optimark, etc..]. A person has to review many articles/publications to start to see the patterns. Clinicaltrials.gov is another source, search for the same listed above.
Topics discussed at the 4th annual NSF symposium, google it.
Focus on your immediate needs of getting a proper diagnosis, that is going to be the challenge. There are other “non-renal” cases of NSF other than me. I prefer not to provide names of “key” researchers/pathways within this forum, it is no doubt being watched/trolled closely.
It has taken numerous wll postioned flaws within the system to reached the point to which the patient population is being used as lab rats. Except the human populations are not afforded the same quality of care/documentation/preventive actions equal to a lab rat. Solely voluntary reporting (ot mandated by law) of drug adverse events to the FDA/Pharmaceutical corps is beyond any form public safety logic.
It is all about the money/profit margins of transnational corporations. Drug induced/caused diseased patients that bring public awareness are just undesirable pawns to some/commodities to others, caught in the middle.

dead_man_walking

Sep. 14, 2010, 11:12 a.m.

Some corporate info and some clinical info about gadolinium contrast. The links are only two of many discussing the known differences in stability between the various gadolinium contrast.

A selected statement from one of the article’s linked below:
“Omniscan and OptiMark have substantially lower thermodynamic stability by a factor of 1,000 or more compared with Magnevist or ProHance.”

Nephrogenic Systemic Fibrosis and Gadolinium: A Perfect Storm:

http://www.ajronline.org/cgi/content/full/191/4/1150

They are an enormous number of articles in the public realm discussing research of the various gadolinium contrast and there link to NSF-NFD.

Stability of linear and macrocyclic gadolinium based contrast agents.
http://bjr.birjournals.org/cgi/content/full/80/955/581

Yes, one could argue this or that about research/opinions, but that is good science, when research/opinions are suppressed, that is bought/flawed/dangerous science.

dead_woman_walking

Sep. 15, 2010, 6:13 p.m.

I’m going to keep a low profile for now and see if I can get a diagnosis but I will be back.  Thank you for all your help.

dead_woman_talking

Sep. 15, 2010, 8:38 p.m.

What bothers me is why GE continues to promote Omniscan and Bayer continues to promote Magnivist with these issues of instability fully documented don’t they realize they will lose every time in court or is it a calculated risk?  They know their going to get sued but the revenues generated and the profits derived from those revenues far exceed their loss from lawsuits.  I wonder.

I also wonder why health insurance companies and companies that are self-insured are allowing these toxic gadolinium based contrasting agents to be injected into their insured knowing the result is going to be astronomical health care costs for those impacted by GBCAs.  It has to be costing them billions in additional health care costs don’t you think? 

If I were an executive in the healthcare field or in HR at a company that is self-insured GBCAs would be on the top of the list of medical products to lobby against.  Getting these GBCAs banned would increase their profits by double digits if I’m any indication of added healthcare costs per incident.  They would be well served to work with victims to get these products banned.  But GE and Bayer probably have more power than these entities or they don’t care to fight with them for the sake of the patient.

dead_man_walking

Sep. 16, 2010, 10:24 a.m.

d_w_w, you are correct on all points, including which entities have more power than (if not invested in) all the others. It is a good decision to lay low until a proper diagnosis is obtained. I’m going to continue to provide my opinion/links (the bigger picture) so others might find an interest and help prevent/stop this insanity. Anyone that is a patient or not in this country is subject to be the next victim. No need to respond, unless desired d_w_w.

Major pharmaceutical corporations & even the medical industry to a certain degree utilize a business model of “risk management”. When that “risk management” is applied to human lives,,,,,,,well,,, here we are.


The profits made from a drug always exceed any “civil” litigation cost’s (less than 10% of the profit margin) when the drug is finally determined (via years of civil litigation/patient suffering-pre-mature deaths) to carry a higher risk (proven to cause harm-death to patients) than benefit to the patient population.
Couple that insanity with well placed/deadly flaws within the FDA regulatory structure (voluntary reporting of drug adverse events/obvious conflict of interest (major funding by the same industry they are regulate), well,,, here we are again.
Think the Federal Mineral Mines Management Agency/Royalty-in-Kind agency that were funded by petroleum industry, the same industry they were charged with regulating. The Royalty-in-Kind program was busted for about every ethical violation known, including some criminal findings, the other,,,,well the BP/other oil spill(s) in the Gulf of Mexico sums up the MMM. Now,,,,with that point made,,,,now think the FDA being heavily funded by the pharmaceutical/medical industries they are charged with regulating. The big picture they do not want the public/patients to realize.
The FDA CDER divisions will not ever be able to make life saving (patient safety/honest risk-benefit ratios) regulatory decisions as long as drug post marketing ADVERSE EVENT REPORTING to them is solely VOLUNTARY/NOT MANDATED BY LAW. Pharmaceutical industry is one of the largest, if not the largest lobbyist in DC.
The link below is to one of many documentaries with former industry insiders discussing pharma-(pushing drugs)-medical-(playing dumb) industry profits being placed before patient safety.

http://www.moneytalksthemovie.com/

I challenge all readers to prove me wrong?? Better yet,,,for those that know me,,,,I’m listed in the MDL1909 yellow pages,,,,,do what you do best,,,,,,silence me, after-all civil case settlement is relatively a small cost (risk) in placing profits before patient safety (pushing drugs).

I just had an MRI with contrast. I was so busy with so many other things, I did not do my usual research before being exposed to this gadolinium. I will call the lab to ask which type or company they used, but it does not take a rocket scientist to understand that if even one fatal case, or even non-fatal case of NSF was caused by this poison..REMOVE THIS POISON FROM THE MARKET IMMEDIATELY!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! I am absolutely flabberghasted to say the least that this was not doen as soon as they discovered the first case.
Suffice it to say I have not been feeling well since the procedure. OMG.. I pray I don’t get NSF. To think I was dealing with trying to rule out breast cancer, and now I don’t know which is worse!

dead_woman_talking

Sep. 28, 2010, 8:23 a.m.

Carol, this is why I had an MRIs to screen for breast cancer and now I’m looking at going on disability.  Why the FDA continues to allow this to go on I don’t understand. 

If you have ever had a biopsy done have the tissue sent to a reputable lab to check for the presence of gadolinium.  My guess is they will find it in that tissue.

Take care and I’m sorry you have to go through the agony of finding out what is making you sick.

dead_woman_talking

Sep. 28, 2010, 8:29 a.m.

Carol the tissue would have to have been taken after the injection of the gadolinium based contrasting agent.

This article is part of an ongoing investigation:
Omniscan

Omniscan: Specter of MRI Disease Haunts General Electric

A rare disease linked to MRI scans has left GE fending off claims of liability.

The Story So Far

General Electric is in a liability fight over a rare and sometimes fatal disease that has been linked to a dye used for MRI scans, with a preponderance of cases involving a GE product called Omniscan.

The disease, nephrogenic systemic fibrosis, or NSF, isn’t fully understood, but nearly all cases have involved patients with kidney problems who were injected with MRI contrast agents.

More »

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