Wednesday, January 14, 2009

When Investigators Bite the Hand That Feeds Them

... it can get ugly:
A scientific dispute has become a slander suit, in a legal case involving NMT Medical and its device for closing congenital holes in the heart.

The lawsuit, pending in London, was filed in 2007 by NMT Medical after a clinical trial failed to show that its device could eliminate migraine headaches in people with the congenital heart opening, known as a patent foramen ovale, or P.F.O.

NMT Medical contends that one of the British researchers in the study slandered and libeled it when he was quoted in an online publication as saying the trial may have failed because the product did not work well. The researcher, Dr. Peter Wilmshurst, was also quoted as saying the company had withheld trial data because it feared that it might undercut sales of the device for other uses, like stroke treatment.

“I’m not as concerned about the companies as I am about the fact that the patients who are in the studies will suffer,” Dr. Wilmshurst was quoted by the publication,, which covers cardiology.
The controversy surrounding this trial has been ongoing since 2007 when Dr. Wilmshurst stated:
In an interview with heartwire (registration required), Wilmshurst, a cardiologist, alleges that NMT has attempted to marginalize his role in the trial--including claiming that he was never a co-PI for MIST I--and to bar his hospital from participating in MIST III. He also asserts that NMT has repeatedly blocked his attempts to view the complete MIST I data set, lied about whether echocardiograms from the MIST patients have been independently reviewed, and massaged the data to portray its PFO device in the best possible light.
But we must continue to ask where are the regulators in this case? Why has this contentious argument between corporation and investigator been permitted to come to one of litigation?

What a mess.

While this trial has exposed the underbelly of the scientific process when egos, patient interests and business interests collide head-on, the new legal actions also make a mockery of England's regulatory process to resolve these differences before they reach this level of contentiousness.


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