A controversial article about problems with an implanted cardiac device -- published by and then withdrawn from the journal Europace -- has been resubmitted and is under review, according to the journal's editor.Hopefully, the journal will explain why they failed to notify their readers about the withdrawl as well. To withdraw an article of such signficance to their readership without explanation should not be tolerated by the scientific community.
"I expect that a decision on publication will be made very shortly," John Camm, MD, of St. George's University of London, told MedPage Today in an e-mail.
Several other issues:
- Perhaps even more concerning this whole ordeal has been the FDA's management of the device report made to them in May. It seems public reporting of Biotronik's filing did not appear on the MAUDE database until after my blog post was published in October.
If this is their policy to withhold reports in patients that are injured for this length of time irrespective of "cause," there are bigger concerns with the government's policies that should be immediately addressed.
- I should also explain my rationale for my "defensive blogging" earlier, too.
The Fair Use Act of US Copyright law has been a favorite place for malicious lawyers to attack bloggers who republish content in their blogs. Irrespective of whether or not one could defend their actions in the court of law on the consitutional basis of "free speech."
But when challenged, as soon as a lawyer gets involved, thanks to the large costs involved, you've "lost" your case even before going to trial. I did not need that expense at the time, so I caved and withdrew the pictures I had published (note: they have since been republished on the blog Cardiobrief.org, courtesy of Google cache, but have included a pdf of my copy of the entire case report in this blog post).