GE Hawks Discount Deal: After its MRI Dye Linked to Rare Kidney Disease

October 16, 2009

(ChattahBox)—General Electric’s profitable $17 billion health-care division is facing the prospect of a litigation nightmare, as the company is besieged with an increasing number of lawsuits claiming harm from GE’s MRI dye. The dye is linked to a rare and often fatal kidney disease that affects patients with weak kidneys, after they are injected with the dye before undergoing MRI scans.

Other companies produce similar dyes that are also linked to the rare kidney disease. But regulators and researchers in the U.S. and Europe say that GE’s dye, Omniscan is linked to more instances of the kidney disease than other dyes. GE responded by saying there is no proof that its dye causes disease. And to prevent a dip in sales of the MRI dye, the company offered discounts of Omniscan to its customers.

A recent expose by Jeff Gerth, of the nonprofit journalism group ProPublica, shed light on the growing evidence that GE’s Omniscan presents a danger to the public. However, both GE and the U.S. Food and Drug Administration are at pains to lump Omniscan in with other so called, contrast agents, asserting that they are all equally risky.

In 2006, medical regulators in Denmark informed GE that 25 patients in Denmark and Austria, suffered from nephrogenic systemic fibrosis (NSF) after they were injected with Omniscan before receiving MRIs. All of the patients suffered from compromised kidneys. Since then, Omniscan and a similar product produced by Bayer and other companies have been linked to cases of NSF.

According to ProPublica, NSF is a painful and often fatal disease with no cure:

“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.”

But Omniscan alone, has been linked to a disproportionate number of NSF cases. In fact, the FDA’s own doctors concluded that GE’s Omniscan “had most of the cases and less of a share of the market. In 2007, the American College of Radiology issued a warning “…that Omniscan posed a greater risk than rival products.”

After the warning by the radiology group resulted in several hospitals discontinuing its use of Omniscan, GE aggressively pushed its financial incentives to buyers of Omniscan.

“GE responded to the marketing challenge by making it easier for hospitals to receive financial incentives if they continued to purchase some Omniscan, according to court records and hospital executives,” wrote Gerth.

The FDA in May 2007, issued an across-the board warning, ordering manufacturers of the contrast agents to display prominent black box warnings, alerting doctors to the risks of NSF. The agency did not contraindicate the drugs for any patient. The FDA news release did however, list Omniscan as the drug most often associated with NSF cases.

Hospitals and doctors are now advised to screen patients for kidney disease, before administering MRI dyes.

And what did GE do after the FDA warning? Offer further discounts for Omniscan of course:

“After the FDA issued its blanket warning, GE reinstated requirements that customers purchase certain minimum amounts of Omniscan in order to receive financial incentives, according to Kathryn E. Goldstein, a spokeswoman for Novation, a purchasing organization for 25,000 health-care providers.”

Dr. Emanuel Kanal, a professor at the University of Pittsburgh Medical Center, is outraged by GE’s marketing incentives, for a product that is disproportionately linked to NSF. Kanal says, “‘that the FDA’s decision to lump all contrast agents together is “inappropriate and indefensible.”‘

Kanal claims that the FDA’s stance on Omniscan “potentially “endangers American citizens.”

Kanal, plans to present fresh data to the FDA, showing the unique danger of Omniscan. The FDA said, “We want to see it.”

Meanwhile, victims with NSF, or relatives of those who have died from the disease, have filed more than 400 lawsuits against GE, Bayer and two other makers of MRI dyes. About 300 of the lawsuits involve Omniscan. And GE’s Omniscan only represents about 30 percent of the MRI dye market.

See ProPublica for more


Comments

2 Responses to “GE Hawks Discount Deal: After its MRI Dye Linked to Rare Kidney Disease”

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  2. Cynthia on December 16th, 2009 9:20 am

    An FDA advisory panel just recommended that the warning for Covidien’s Optimark and GE’s Omnisca—drugs in the family of medications known as gadolinium-based contrast agents (DBCAs)—be updated to restrict their use in patients with severe kidney disease because of the potential for an increased risk of nephrogenic systemic fibrosis (NSF). NSF causes thickening of the skin and organs. GBCAs carry a strong “black box” warning. This site has good information on this issue: http://www.gadolinium-mri.com/index.html

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