Monday, August 31, 2009

NMT Medical - the MIST trial starts to unwind

I have posted previously (here and here) about this ethical and scientific scandal. The saga involves a medical device, and the conduct and conclusions of the Migraine Intervention with STARflex Technology (MIST) I trial. Peter Wilmshurst and another "author" of this study alleged scientific misconduct, hiding of data from authors and legal bullying by the sponsor, NMT Medical. They refused to sign the manuscript, made their views public, and were sued.

Now the remaining authors have been forced to submit an extensive manuscript "correction" which addresses a few of the many problems raised. Amongst other things there is an admission that "side effects" of the device were misrepresented. Devices embolized inside the heart and to the left pulmonary artery. A device that embolised into the pulmonary artery was reported to be in "an unsatisfactory position" and was not mentioned at all in the paper (or apparently to the Ethics Committee). The stated "authors" declare that they "regret" the "errors".

The Journal (Circulation) did not question the changing authorship on the four versions of the paper that they received. The Editor in Chief of Circulation (Dr Loscalzo) earlier wrote to say that "We now consider the matter closed". The UK regulator, the Medicines and Healthcare Regulatory Authority (MHRA) previously stated that it had "reviewed the "available evidence" and has found nothing to suggest that there is a problem". Since the ejected authors and presumably the regulators had no relevant evidence at all, the MHRA response and their definition of "a problem" appears predictably odd to say the least.

The text of the statement of "correction" is here.

I don't think that this is going to be last word on this sorry matter.

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