The Spectre Haunting GE

BusinessWeek:

Many MRI patients are injected with a GE dye to enhance images. If they have weak kidneys, they might develop a rare and sometimes fatal disease.

n May 2006 medical regulators in Denmark issued a warning that signaled trouble for General Electric (GE). Danish researchers noted that, over a four-year period, 25 patients in Denmark and Austria had suffered a rare and crippling disease after undergoing an MRI, the scanning procedure used to diagnose everything from brain tumors to blown knees.

Read the whole story: BusinessWeek

Comments

[Stock market]

Unemployment still out of control and unfortunately we do not have anything that even
resembles a jobs plan from our wonderful leaders. Bailouts, tarp, health plans but no jobs.

hat tip to: http://tiny.cc/financenews

If this is change we can believe in, count me out in 2012

[ReedYoung]

Page 1 says nobody knows why Omniscan kills patients with weak kidneys, but on page 2:

>
Omniscan and comparable products contain the potentially toxic metal gadolinium. During MRIs, the metal helps physicians see the brain and other parts of the body. Healthy kidneys filter out gadolinium. But patients with severely impaired kidneys can become victims of NSF, according to the FDA.

NSF starts with painful swelling in the legs and arms. It progresses to lesions in the skin and connective tissues, and it can attack organs, causing death. So far, there is no cure.

... A "causal relationship" between NSF and gadolinium-based contrast agents "has not been established," the company said.
<

That last sentence is GE's real problem; while the toxicity of the key ingredient, gadolinium, and the inability of impaired kidneys to filter it from patients' blood were already well-known, GE claimed that a "causal relationship has not been established." The causal relationship had perhaps not yet been scientifically proved beyond a shadow of a doubt in every case, but the *danger* was well known and GE subjected patients to that danger KNOWINGLY. $1 Billion, split among 300 patients and their lawyers, is not enough.

[porsche996]

NYCOMED developed the drug Omniscan and distributed it.

All of the research pointed to problems with the drug in the presence of severe renal insufficiency on dialysis or patients with seriously diseased liver's or transplants.

This was disclosed to physicians using these types of GDCA agents.

Nephrologists and Radiologists seeking some safe method of evaluating renal grafts or transplants used Omniscan to do imaging studies because in a risk to benefit ratio having the study was more beneficial than not in that patient population and x-ray contrast medias are particularly toxic in these patients. They used Omniscan against label advice.

More than 200 million patients have received injections of GDCA formulations.

Less than 200 adjudicated cases of NSF in patients that had GFR's below 30ml/min (renal compromise) are the result.

The FDA was correct to black box the Linear formulations of GDCA but it is probably a mislabeling and unnecessarily harmful to the cyclical compunds of GDCA like BRACCO's Multihance that have no history of NSF associated with its use.

[porsche996]

GE MRI contrast medias have been responsible for far fewer injuries and deaths than Halliburton and Blackwater.

Taking a shower in a facility built by KBR/Halliburton in Iraq or Kuwait or riding in the streets of Baghdad behind a Blackwater escorted convoy can k*ll or injure you at a much higher rank of probability with a great deal less compensation for your damages and loss.

[wbwbruce]

GE knew about the affects of Gadolinium back in 2000 they did nothing. They did not warn anyone about the affects of this dye untill the FDA put a black box warning out in 2007. So do not feed me or anyone else your BS. I am Cripple because of Gadolinium.

[porsche996]

GE did not purchase NYCOMED/Amersham's Omniscan until 2006. The possible harmful effects of GDCA in patients suffering from known renal insufficiency (dialysis patients) or Liver transplants were documented in 1992. Any use of the drug in this patient population was done in order to prolong their life on dialysis and deemed an acceptable risk compared to certain death if they did not have an MRI study to identify the patency and viability of transplants or of new vascular shunts.

[porsche996]

GE MRI contrast medias are safer than a Halliburton contract to install military showers in Iraq and Kuwait.

[gespenster]

You mean the same company that has been going to bat for this administration for government contracts and agreed to incorporate the Administration's agenda into its entertainment division?

You don't say.

Leaked memos directing programmers to include administration policy:

http://bighollywood.breitbart.com/jjmnolte/2009/10/15/leaked-memo-reveals-the-white-house-has-control-of-your-television-set/

[porsche996]

So that's why thousands of patients deserve to be frightened and scared to trust their health care practitioners by the Republican MSM?

Republicans the party of D*ath want to slam GE for supporting the administration's health care reform efforts?

GE bought NYCOMED in 2006, GE inherited this liability issue when it bought NYCOMED's assets and patents.

MRI contrast medias are safer than a Halliburton contract to install military showers in Iraq and Kuwait.

[porsche996]

HP using the term 'DEADLY MRI DRUG"

Now that's responsible journalism....

[ReedYoung]

In fact, it is. RTFA.

[joebaggadonuts]

I couldn't find the name of the dye or contrast agent in the article. Why not? Don't the reporters know?

[Sumocat]

Is it because you didn't even try to look for it? Seriously, it's in the first paragraph of the source article and repeated throughout.

"The GE product, Omniscan, has since been linked to other cases of the disease, which appears to affect only MRI patients who have kidney problems."

Omniscan: http://md.gehealthcare.com/omniscan/

[joebaggadonuts]

Reference 1 in the link, not in the article says this: References: "1. Data on file, Amersham Health."

If you dig through the rest of the notes it says "Galadinium-based." The article could have said that "Omniscan is a proprietary Galadinium based contrast medium" and saved us all the trouble.

[porsche996]

This is typical of the critical reading comprehension skills of lay people trying to interpret scientific documents and research data.

[1differentdrummer]

Come on, let the market work. It's self-correcting. Let enough people die and another product will replace it.

[autumncolors]

If those making millions start paying taxes at 50% to 60% and there are no offshore tax havens, the rampant greed would be curbed.

[donttasemebro]

Along with entrepreneurial spirit. Trust me, that is not the answer.

[KHAAANNN]

Really? History says you're wrong.
In the late 1950's under Eisenhower the top tax rate was 90%.
Are you saying there were NO ENTREPRENEURS in the 1950's?
In the 1960's under Kennedy/Johnson/Nixon the top tax rate was 65%
Are you saying there were NO ENTREPRENEURS in the 1960's?
I could go on, but you won't understand anyway.
There are fewer entrepreneurs now, not because of TAX POLICY, but because the Monopolies and Patent Laws prevent people from entering markets with new ideas and the Venture Capital markets demand 150% returns in 3 years, something which startups that want to build a wide market cannot do.

[barksalot]

Perhaps the President should talk to his pal Jeff Immelt about this. As a big proponent of green technology, cap and trade, and a safe environment why doesn't he include his own company in any of these?

[lovesds]

Maybe Adrianna needs to talk to her buddies at GE,MSNBC,CNBC AND NBC. Oh forget Adrianna got her money thru marrying a rich republican.

[1differentdrummer]

That's a wrong thing?

[sueno]

Investigate, investigate, investigate!
Do you know how many people
have taken such tests? thousands daily.
This can be compared to the swine flu scare,
only people are being poisoned on purpose.
Investigate, investigate, investigate-

[Clairvaux]

Giant corporations are loose cannons in our society.

They create jobs and products, but they also do great harm. Their political influence is obscene.

We have to control our corporations or they will ruin our Republic.

[bola47]

ge could care less. as the largest polluter in ny state, why would a few deaths bother them?

[thepoliticalcat]

It looks as if there has been some misfeasance on GE's part, which is the real reason that they are now facing *some* action. In the event, the actual people who might be responsible for decisions or lack thereof concerning the safety of this substance will not pay any penalty. If we do not begin holding corporate employees accountable for the effects of their decisions, why should they care about the effects of their actions? They will retire with golden parachutes for having "improved the corporate bottom-line," and that is really all they care about. Ill, injured, and dying patients resulting from their negligence? Doesn't change the profit margin or their retirement plans, does it?

[porsche996]

NYCOMED the company that distributed this product (Omniscan) before GE bought them and accepted their pending liability issues in 2006 always warned practitioners that Omniscan not be used in patients with compromised renal function.

Some screwball Nephrologists and Radiologists in Austria did not read the fine print and began using it to MR scan dialysis patients and some Americans then followed suit....these comprise the overwhelming majority of cases proven adjudicated.

[research]

one of my friends got this syndrome . It took years and several different doctors, and wrong diagnoses and unnecessary drugs and even surgery, all the deal with side effects of this MRI contest agent. It ruined his life. Just another of the 100's of thousands of people hurt by malpractice.

[steppenwolfsayshi]

I bet at some hospitals, the only product they use is Omniscan, because it has been MARKETED to them to be used for ALL of their patients.
The fine print might be there, but if it is sold to them in a dishonest fashion, GE is still the liable party, not the doctors.

[hacksaw]

ge we bring good things to life