Thursday, November 08, 2007

Of PFO Closures and the MIST Trial: Troubling times for Alice in Wonderland

[Click below for link to external article]

[Another update has been added at the bottom]

In case, you have a problem with blogs, here is the "original" article that reported it:

It is your choice to read either article or the blog. Both read like the Oh-la-la of a Hollywood movie, er..the Fugitive. Okay, maybe it is not so dramatic, but our main characters are Dr. Wilmshurst and Dr. Dowson. The playground was TCT 2007 and the (you thought I was going to use the e-prefix, huh?) Corporation is NMT.

Several not-so-mysterious mysteries surround the issue:

Now if everything is both hunky and dory in PFO land, why not show Dr. Wilmshurst the data and shut him up? What is wrong with letting him see the data?

Or what is wrong with proving to him that the echocardiogram data was independently verified?

In fact, why not publicize the entire data set?

Why not conclusively prove and delineate the purported "protocol" violations of Dr. Wilmshurst?

What about Dr. Dowson's seemingly troubled past?

It seems cliched enough, but the silence of NMT (on these questions only) is deafening. See, not answering these questions, to the simple mind, seems to be very troubling.

Essentially, it seems like the MIST Trial seems to be well on its way to becoming a prime example for the "10 Things to avoid", "How to turn your device Trials into publicity nightmares", "It is fun to try and fool all of the people some, most and all of the times" case studies that business schools and a variety of other graduate schools could hand over to avid students worldwide...

I am constantly surprised at how companies with so many "experts" fail to take the easy, simple, honest way out with things. Who knows if the MIST Trial was even wrong in the first place? But things have escalated to a level where that is not even the issue anymore...

Remember, this is only ONE of the several foul-smelling issues raking up in the "increasingly, well-funded, rapidly growing" medical devices industry. For hints look up defibrillators (going back to more than a year, if you please) and Orthopedic devices for other "issues".

Well, if this trend continues, our entire industry is going to look like a bunch of quacks trying to sell sham wands in the place of sham potions..

What this industry needs is people with strong, actually very strong ethics, not blind "several years of experience conceiving, designing, redesigning, launching, manufacturing and hand deliverying devices to patients and surgeons for very, very low pay". Effective leadership in the medical devices industry seems to be its very own holy grail...

By the way, coming back to our friendly, neighborhood PFO-closure mania, this is not the first time I have posted on the subject either. Here is another archive:


Bad coincidence. Just after I published this post, another of my Google Alerts turned this one up:

If that doesn't send a chill down your spine, I wonder what will..

Add to Onlywire

No comments: