Sometimes news comes in bunches. That’s not typically the case in the month of August, which is ordinarily a pretty quiet month. Not this year, though. Here are three stories that stick out, in one case like a sore thumb.
Post-market studies for ICD leads
FDA announced it will require section 522 studies for a range of ICD leads made by St. Jude Medical. This is not the first time the new FDA has required 522 studies for groups of devices as the 522 orders for surgical meshes, hip implants, and dynamic spinal stabilization systems suggest. I might add that companies whose wares have not presented statistically significant problems have been forced into the 522 march.
The lesson here is that a post-market 522 study is now the quasi-official FDA response to device problems that are not already tracked in a very extensive registry, and industry knows it. What will industry think about investing in the U.S. in the years ahead once they have to factor the cost of these studies into the product life cycle?
Hauser’s paper on abrasions: a correlation with extrusion?
Robert Hauser, MD, recently published in Europace on the matter of abrasions to St. Jude leads coated with the Optim co-polymer material. It’s another piece of news that could spell danger for patients and for the company … or not.
One thing Hauser’s piece did not explain was whether a correlation exists between abrasion from external sources and externalization of conductors. Maybe there aren’t a lot of data on this. I can’t seem to locate anything on this for ICD leads in general, let alone anything specific to the Optim coating. Will it turn out that the correlation between abrasion and externalization is puny?
One of the difficulties behind this discussion is that there are a lot more patients around who have had an ICD for some years than there were in times gone by. Consequently, electrophysiologists are cramming these skinnier leads into some spaces where there is already a lead that has gone kaput. Ergo, a higher rate of abrasions and externalizations might be partly or even principally due to the contortions a lead is exposed to in order to cram it into a tight anatomical space.
This is not a meaningless consideration. If there’s already a lead in there and you as a physician always resort to a skinny lead to replace a dead lead, the narrower lead already has a problem.
So before we wish skinny ICD leads out of existence by beating the daylights out of St. Jude, maybe we better find out if there is a correlation between abrasion and extrusion, and whether these leads are being used in ways that make it tough to avoid problems to begin with.
NEJM article on NIH spending
I mentioned at the outset that one of these three stories stuck out like a sore thumb. Here it is.
Those who have watched the MDD Perspectives blog for some time know how annoying I find the entire NIH funding discussion. Well, it’s still annoying.
I won’t carp about the cancer-versus-Alzheimer’s funding thing, but the authors of the paper on NIH spending in the Aug. 23 edition of the New England Journal of Medicine use advances in heart disease to justify more spending at NIH and the National Science Foundation. But really, doesn’t the medical device industry deserve most of the credit?
Another point raised in this and other arguments like it is that people with PhDs and MDs will find themselves unemployed. Well, there’s a lot of that going around lately and it’s no reason to throw taxpayer money at medical research. By that logic, anyone with a PhD in particle physics or a JD in constitutional law deserves to be employed via federal funding just by virtue of having a sheepskin. You never hear anyone sweating bullets over someone with a Bachelor’s degree in criminology, but if you have a PhD in a life science, well by golly, pull up your chair to the trough!
I dare someone who supports gobs of money for NIH to say “FDA needs it more. We’re okay with NIH funding where it is.” Why will that never happen? Because possession of a PhD does not blunt self-seeking behaviors even a tiny bit.
Funny how human nature never changes, isn’t it?