A healthcare firm is seeking to silence a Danish academic from expressing doubts about one of its products by using England’s draconian libel laws.
You might recall the anti-inflammatory drug, VIOXX. It was a Cox-II inhibitor that produced very little tummy problems as compared to the sulfuric acid in pill firm also known as Naproxen (Alleve).
The drug performed well in clinical trials, and the FDA approved VIOXX for use in the US. Well, clinical trials are usually sufficient to identify the larger problems with a drug, but not large enough to identify the serious problems that only occur rarely.
In the much larger scale of the general public receiving prescriptions for VIOXX, the opportunity for those rare adverse events increases. (Some clinicians call the first few years of a drug's release as extended clinical trials at the public's expense and without protective protocols involving human subjects.)
In the case of VIOXX, the rare adverse event was death by heart attack, though I'm sure the clinical description was far more impressive. This problem only arose with prolonged use. Short term use presented no observable problem, but few, if any, were willing to take the risk, as no one knew where the boundary was between short term and long term use.
Sadly, I found VIOXX to actually do its job on my feet, far better than Celebrex, and without the stomach problems caused by Naproxen.
However, the maker of VIOXX did not threaten to sue the clinicians who identified the problem with the long term use of the drug. The maker just took the drug off the market.
In the EU, the situation is different. A medical researcher uncovered an association between the use of an MRI contrasting agent in patients with poor kidney function and the subsequent development of a rare disorder in which the skin swells, thickens, and tightens. There is no cure. Life in a wheelchair often ensues. The disorder has killed on patient.
And of course, the medical researcher has done what researchers do. Publish. Present. Speak.
GE Healthcare has taken exception to the clinicians reports and publications, and the subsidary of General Electric has taken to suing the researchers for libel.
I'm just not sure how medical research and peer review publication sets the stage for a libel suit, but then I'm not the least bit familiar with laws in the UK and much less in the EU.
I just hope that nonsense stays across the Alantic.
-- text tapped from a virtual keyboard.
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