The Spectre Haunting GE

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

Illustration by Paul Dallas

By Jeff Gerth

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Imaging safety expert Kanal has concerns about the GE dye used with MRI scans Michael Nemeth/Wonderful Machine

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Editor's Note: Gerth is a reporter with ProPublica, a nonprofit journalism organization in New York. For more on GE and MRI drugs, go to http://www.propublica.org.

In 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. The patients had been injected with a GE dye that makes images more distinct. They all had weak kidneys before receiving the dye. 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. Similar drugs made by Bayer (BAY) and others have also been tied to the sometimes fatal ailment, nephrogenic systemic fibrosis (NSF).

Some regulators and researchers in the U.S. and Europe have found that a disproportionate number of NSF cases are associated with GE's Omniscan. That threatens to create a costly liability mess for the company's growing $17 billion health-care division, which GE promotes heavily with its "Healthymagination" ad campaign. The company's diagnostic products generate about $1.8 billion in sales. GE doesn't provide financial figures on Omniscan.

People with NSF, or relatives of those who have died, have filed more than 400 lawsuits in U.S. federal courts against GE, Bayer, and two other makers of similar drugs in the past several years. About 100 cases don't concern Omniscan. Of the roughly 300 that do involve the GE drug, about 70% relate exclusively to Omniscan, according to court records and lawyers on both sides. Bayer HealthCare has some 50% of the U.S. market, regulators estimate. GE is next, with about 30%.

While GE says it is investigating concerns about Omniscan, the company maintains there is no proof that the drug, known as a contrast agent, causes disease. "NSF is a complex disease with a number of contributing factors," GE said in a February 2009 position paper. It conceded that a critical ingredient in Omniscan and other agents may be one of those factors, "but not necessarily an essential [one]." Scientists concur that they don't fully understand how the disease starts, although nearly all cases have involved patients with kidney problems who were injected with MRI contrast agents.

The U.S. Food & Drug Administration has required since May 2007 that makers of contrast agents use a stern "black box" warning cautioning physicians to weigh carefully the benefits and risks for patients with weak kidneys. Screening out people with kidney problems appears to eliminate the danger of NSF. But the FDA has not said GE's product is any more problematic than those of its competitors. The agency reached that conclusion even after two of its staff doctors—in findings disclosed here for the first time—determined that Omniscan is riskier than its rivals. GE had urged the FDA to treat all of the agents as equally risky.

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