NMT Medical closes migraine trial in U.S. - a case to watch

This news-snippet rings a few alarm bells. I have posted about some apparently dodgy dealings in a clinical trial involving Boston-based NMT Medical, the MIST I trial, and UK clinical investigators.

The previous saga involved a medical device, and the conduct and conclusions of the Migraine Intervention with STARflex Technology (MIST) I trial. MIST I had two co-principal investigators:
  1. Dr Peter Wilmshurst, a respected cardiologist and
  2. So-called headache specialist Dr Andrew Dowson. Although Dowson described himself as a neurologist, he is not. More importantly, Dowson has restrictions on his medical practice following previous research misconduct.
Wilmshurst states that NMT has repeatedly "blocked his attempts (as principal investigator) to view the complete MIST I data set, has lied about whether echocardiograms from the MIST patients have been independently reviewed, and has massaged the data to portray its PFO device in the best possible light". He was sidelined from the study, his concerns were ignored, and Dowson presented the findings which have now been questioned. For details see here.

Several ethical, procedural and scientific issues arose in MIST I which went beyond the issue of migraine to other aspects of the device. One can only hope that NMT are not going be so foolish as to attempt to threaten Dr Wilmshurst for quite properly discussing scientific procedures involving patients. The of MIST I is ongoing, and it seems that NMT may have resorted to legal threats - always a credible scientific tactic. This case is worth keeping on the radar.

Now we read that NMT is shutting down the MIST II trial. This may be appropriate as MIST I showed no efficacy for migraine. However questions have to be asked when trials are shut down. If the continuation of MIST II was in any way dependent on the outcome of MIST I, then the ethics of starting MIST II have to be questioned. If the termination was truly related to difficulty with recruitment then this raises other issues.

NMT Medical closes migraine trial in U.S. Mass High Tech, 23 Jan 2008
NMT Medical Inc. reports plans to shut down its migraine technology trial, MIST II, to instead focus on using its technology to prevent the onset of stroke.

According to officials at Boston-based NMT, the move should save the company approximately $14 million over the next two to three years, as it redistributes funds originally budgeted for MIST II (Migraine Intervention with STARFlex Technology). NMT has stopped enrolling patients in MIST II, which was being conducted at 20 centers in the United States.

NMT president and CEO John E. Ahern said that strict enrollment requirements from the U.S. Food and Drug Administration has made MIST II an expensive endeavor "with little likelihood of being completed in a reasonable time frame."
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