Welcome to Dr. David Braxton and his new pathology weblog StemPath which will focus on stem cell biology. Best of luck to Dr. Braxton--make sure y'all check up on this one regularly as he gets off the ground.
Dr. Keith Kaplan at Digital Pathology Blog pointed this one out as a good article discussing the recent FDA meeting regarding whole-slide imaging (WSI) technology. And he has some informed insights quoted in the article. The online version of CAP Today has been out and I (again) urge you to check it out--although the hard copy version is probably sitting on your desk somewhere.
I reckon that you're take on this article might depend on your reaction to the quote from Ole Eichhorn ot Aperio:
"Eichhorn believes that the FDA fears that if it doesn't "get out in front" of digital pathology, there could be a proliferation of non-cleared/non-approved WSI systems "because these devices are useful and valuable. By the way, that's what we have with the microscope"."(my emphasis)
If a device is already "useful and valuable" (as judged by me, a practicing pathologist or as judged by the marketplace of laboratories and pathologists), shouldn't the FDA just let us use these for making our diagnoses--like we already do with microscopes? As in golf (with a similar governing body deciding what is allowable equipment and what is not), it's not the club, it's the player that makes the shot and records the score. If I'm a crap player (okay, I admit it), it won't matter whether I have an approved or non-approved club, ball, grip-warmer, etc.--I'll still be a crap player! The imager and software is NOT making the diagnosis, the pathologist is! And I'll freely admit that the instrument/software might (sorry, I'd still like proof) be better at counting stainable events at statistically important cut-offs or at least doing it faster. BUT I would also submit that whether a breast cancer is positive for ER at 21.38% or 25% to 50%, the clinician is going to look at my Allred score to determine treatment (sorry, Keith, that's where I slightly disagree with your statement as it is in the article). The "precision" offered by these instruments for this use is a little disingenuous and adds a patina of "scientificity" that really isn't that clinically meaningful.
If the FDA wants to collaborate with CAP and industry groups to provide guidance on how we should validate these instruments in our own labs, I'm definitely on board with that.
I think too that you really have to also keep in mind the various people at the table and ask what their own vested interests are in this process--not that I'm cynical or anything, but still.
It seems that the CAP has taken a reasonable position, as articulated by Dr. Valenstein, but I would like to review the actual consensus position--which I cannot find on our (the CAP) website. Can anyone else? We really need real pathologists out there expressing their opinions on this stuff to the CAP and to these regulatory agencies.
Dr. Sachin Jain writes an insightful editorial (free text) in the Thursday last (August 13) New England Journal of Medicine. On the "friend request" on Facebook of a former patient:
"The anxiety I felt about crossing boundaries is an old problem in clinical medicine, but it has taken a different shape as it has migrated to this new medium."
Dr. Jain brings forth some pertinent issues regarding social-networking sites as they relate to individual physicians, to doctor networking groups, and to institutions. One point of interest for me in this editorial is the issue of "professional distance."
Societal trends over the last 50 years have radically foreshortened this distance between doctors and patients, doctors and other members of the "medical team," and between doctors themselves. Something to reflect on: compare depictions of these relationships with respect to professional distance in literature, movies, and television over the last 150 years or so. Social-networking seems to be only accelerating an on-going trend--but, as Dr. Jain presciently observes, "(w)hat is different about the online arena is the potential size of the community and the still-evolving rules of etiquette (my emphasis)." I wonder sometimes if there is any notion of "etiquette" in any aspect of American life. Perhaps there is hope.
Finally, Dr. Jain points out the inevitable conflict between physicians as "members of real-life communities" and personal behavior that is discordant with our professional "persona." This also is an old problem but becomes magnified and amplified when we launch ourselves into cyberworld.
Digital Pathology Blog has an interesting post on a new application for research which fuses digital slide imaging with MALDI mass spectrometry. This is huge! One of the weaknesses I see with proteomics is that in using mass spec analysis on tissues, you lost any idea where these protein signatures were coming from. After an initial boom in this research a couple years ago, this limitation seemed to really dampen use of mass spec. Excellent post with good links for more info.