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By MARK McCARTY

Medical Device Daily Washington Editor

Over the past five years, I've attended a number of medical device advisory committees, which I'll acknowledge has been very enlightening in a number of ways. Mixed in with all the learning, however, has been the occasional moment that qualified as an out-of-body experience.

I'm aware that many panelists on these advisory committees are engaged in academic research, which necessarily entails inquiries into areas that are considered outlandish or unrealistic. So one might be inclined to dismiss the passing absurdity.

Still, there are times when the remarks qualify as a demonstration of breathtaking stupidity and even callousness. And in at least one instance, I would have understood if a patient with the condition in question had raised his or her hand and asked whether this panelist was really qualified to advise FDA.

Here's an example of a relatively harmless version of this kind of thing. In an advisory hearing last year, one panelist asked whether a study of radiologists' readings of scans should control for whether the radiologist had consumed coffee that morning.

The practical ability to control for such a thing sounds like a stretch if only because tea also has caffeine, not to mention all the canned and bottled beverages that deliver their own doses. Upon hearing this suggestion the first time, the other panelists fell silent, but this panelist would have none of it. She stridently brought it up again later in the day, when one might assume the responses from the rest of the panel were perhaps less directly influenced by their morning jolt of java.

News flash: The rest of the panelists' afternoon responses suggested that their views of the effects of caffeine were independent of their serum caffeine levels.

In a more recent advisory hearing, however, two panelists did a nice job of making themselves candidates for the Advisory Committee Hall of Shame. This hearing dealt with a treatment for a terminal cancer that would be approved only for patients whose disease twice failed to respond to other therapies, so it was not a light-hearted discussion. These patients are almost guaranteed to die within six months.

One panelist asked whether the treatment had been tested on healthy subjects, an absurd proposition on the face of it. As an example, it's not easy to get a healthy patient to climb into an MRI machine given how tight the spaces are, and one also suspects that it's just about impossible to get healthy subjects to volunteer for a CT scan for the sake of science, thanks to the recent flap over radiation dosing. The therapy under consideration is as yet utterly unfamiliar to the general public, so what are the chances? The balance of the panel declined to remark on the remark, and fortunately for all, this panelist let it drop.

But the development at this panel that really stuck with me was the vote by one panelist that the treatment in question - we're still talking about a treatment for a twice-refractory, incredibly lethal cancer, mind you - passed the test for safety and for efficacy, but this member of the panel nonetheless had the nerve to decree that the risk-benefit ratio was not up to par.

As someone who has never had to deal with the disease in question, my involuntary reaction generated a thud as my jawbone hit my collarbone. To me, it was the kind of response one might expect from the mentally deranged, and it smacked of the grossly irresponsible intellectual adventurism for which academe is too infrequently excoriated.

After the hearing had ended, however, I started thinking about how I might have reacted had I been one of the patients in the room, or one of their loved ones. Again, these are patients who have twice endured chemotherapy and whose lives are about to end. And I have to tell you that as a patient with this disease (or someone who cared about such a patient), I'd have found it exceedingly difficult to resist the urge to walk up to this individual and slap him hard across the face for such arrogance.

I know that sounds like an over-reaction, but to reiterate, these are people whose lives are fast coming to an end. They are staring at the prospect of never seeing their loved ones again, and bidding farewell to the only voyage through this existence they can be sure they'll ever have. Some will leave growing children behind. They all watch as their spouses, siblings, children and parents struggle with the devastating implications of the diagnosis.

And through all that, a member of the academic community has the nerve to say the treatment offers good safety and efficacy profiles, but that the risk-benefit ratio is lousy?

As the saying goes, excuse me?

Academe's propensity for rhetorical adventurism is documented, but this kind of self-gratification is more than just conspicuous. The seven-year-old on a bicycle says, "look Mom, no hands!" The 47-year-old member of an advisory committee says, "look Mom, no ethics!"

I'm not going to pretend that we in the media are innocent of extravagances, but FDA is not taking its cue from Medical Device Daily, even if some on Capitol Hill seem inclined to micromanage FDA with the help of the New York Times.

After this last episode, though, I've concluded that FDA should ask itself whether all the fruits of academic speculation are benign, and whether anyone compelled toward such exhibitionism should be advising the agency in any capacity. The thought that someone possessed of that kind of selfish, impulsive stupidity has FDA's ear is nothing short of terrifying. It should be grounds for dismissal.



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