General Electric, Renal Risks And A Libel Lawsuit

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omniscanLast month, European medical regulators recommended that anybody who needed an MRI scan should be given a check to ensure their kidneys are healthy if they were to be given General Electric’s Omniscan or two similar contrast agents. And the FDA is conducting its own review.

But Henrik Thomsen isn’t talking about it, even though he heads the department of diagnostic sciences at the University of Copenhagen and is part of a small group of clinicians credited with alerting patients and regulators to the potential risks of Omniscan for renal patients. Why? A talk he gave last year prompted GE Healthcare to sue him for libel, The Times of London writes.

GE has already racked up costs of more than $600,000 pursuing Thomsen, who has authored or co-authored nearly 400 papers and will have to pay GE’s costs if he loses. Campaign groups have warned that vital scientific and medical work is being threatened because of the danger of libel actions. “I believe the lawsuit is an attempt to silence me,” he tells the paper. “It’s dangerous for the patient if we can’t frankly exchange views.”

GE Healthcare appears to have reacted promptly to concerns, the Times writes, but objects to some of Thomsen’s work and decisions by European regulators. GE doesn’t deny an association between Omniscan and Nephrogenic Systemic Fibrosis, but insists a causal link has “not been established,” and that a reporting bias may account for the high number of NSF cases linked to its product.

In the US, docs have been warned of an association. And earlier this month, the FDA said it now believes that Omniscan, Optimark and Magnevist pose higher risks. An FDA advisory panel went further and recommended that Omniscan and Optimark should not be given to patients with severe kidney disease (see here).

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  1. GE Healthcare has promoted a vigorous scientific debate about the safety of Gadolinium Based Contrast Agents (GBCAs), including Omniscan™ and we reject any suggestion to the contrary.

    Like the many other scientists who have contributed to this discussion, Dr. Henrik Thomsen is entitled to express any and all honestly-held beliefs so long as his views as expressed are not knowingly indifferent to the true state of affairs.

    GE Healthcare encourages such scientific debate but the imperative of a robust debate about the safety of gadolinium-based contrast agents does not license Dr. Thomsen to make knowingly false and inaccurate statements about GE Healthcare or its products. GE Healthcare initiated the lawsuit because, despite repeated efforts by GE Healthcare to engage in a constructive dialogue with Dr. Thomsen, he persisted in making false accusations that the company had deliberately concealed and suppressed information from regulatory authorities in relation to its contrast agent, Omniscan. This action is not about the science, it is about the inaccurate statements that Dr Thomsen has made about the company.

    GE Healthcare has cooperated fully and actively promoted a robust evaluation of the safety of GBCAs in Europe, the United States and elsewhere based on the evidence and the science. We welcome the continuation of a principled dialogue about the safety of GBCAs.

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