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GE Lawsuit Quiets Critic of Omniscan

Posted by Jane Akre
Friday, January 22, 2010 7:30 PM EST
Category: Protecting Your Family
Tags: GE Healthcare, Omniscan, Whistleblower, FDA, MRI,

Whistleblower is being sued by GE Healthcare for making what the company calls defamatory comments about  Omniscan.

Libeling A Company

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IMAGE SOURCE: Wikimedia Commons Web site / Omniscan image

GE Healthcare, a British subsidiary of General Electric, one of the world’s biggest corporations, has sued Danish researcher, Henrik Thomsen, a senior radiologist and professor of radiology, who is sounding the alarm about the dangers of the GE imaging drug, Omniscan.

Patients who received the drug allegedly developed a potentially deadly condition, nephrogenic systemic fibrosis (NSF), which occurred among some kidney patients at his hospital at Copenhagen University, reports Business Times online. NSF is progressive and can lead to death. There is no effective treatment for this serious, debilitating disease.

GE Healthcare has reportedly spent more than $600,000 in legal costs pursing Thomsen.

Defamation

The company admits its product has links to serious side effects but says Thomsen falsely accused GE of suppressing sensitive information about the drug’s risks when presenting information at an Oxford scientific congress in 2007.

The company calls that defamation but failed to identify what was defamatory when asked to by the Sunday Times. It may have been “by way of innuendo” the company says.

The lawsuit has accomplished its goal. Thomsen is now refusing to discuss the possible risks of the drug in any public forum in the UK. A former hospital director who is leading a campaign to reform the country’s libel laws says, “It is hard to conceive a stronger public interest than scientists and clinicians being able to discuss freely their concerns about drugs or devices used on patients. Libel laws should not be used in this way.”

Thomsen is among small group of clinicians credited with alerting the public about the potential risks of Omniscan for renal patients. In the UK, medical regulators recommended those patients in need of an MRI scan should receive a check of their kidneys prior to being given Omniscan or any similar products.

In December, an FDA advisory panel recommended the FDA effectively ban for patients with severe kidney disease the use of two drugs that create high-contrast images - Omniscan, owned by GE, and Optimark, made by Mallinckrodt unit of Covidien. A third contrasting agent, Magnevist, the market leader made by Bayer HealthCare, was also the target of the FDA expert panels' recommendation to receive the highest black box warning.

Gadolinium - A Potentially Toxic Metal

Omniscan has been given worldwide and is safe for the majority of people. But it contains the potentially toxic metal gadolinium which is used to enhance images for MRI scans. That has been linked to NSF in kidney patients, which can confine sufferers to a wheelchair.

Five reportedly died in Britain from possible side effects and in the U.S. more than 170 deaths are reported linked to the use of Omniscan.

In December 2006, the FDA issued a public health advisory after 90 patients with moderate to end-stage kidney disease developed NSF and another condition known as Nephrogenic Fibrosing Dermopathy (NFD).

The symptoms include thickened, rough, and hard skin which sometimes turns dark. Also patients may have difficulty moving.

ProPublica, an independent, nonprofit news organization, has been closely watching the effects of medical imaging drugs, divulging the truth about the dangers they pose. #


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