Interagency conflict over Intermacs?
The Centers for Medicare & Medicaid Services recently announced it would no longer require hospitals to forward data from their patients with ventricular assist devices to the Intermacs registry. Depending on whom one asks, that’s a plus for hospitals, but the flip side of that particular coin is that another registry will have to take it’s place.
The problem with CMS seeming to pull the plug on Intermacs is that the National Institutes of Health also has a stake in the registry, and there’s not much indication NIH is also ready to pull the plug. NIH still publishes annual updates to the contents of the registry, such as this report published earlier this year in the Journal of Heart and Lung Transplantation.
Note also that the name Intermacs is an acronym for Interagency Registry for Mechanically Assisted Circulatory Support. Clearly there’s a big potential for a turf war here, especially given that most cardiologists think there’s still a need for a registry for ventricular assist devices.
Demurring on da Vinci
Intuitive Surgical has a raft of lawsuits on its hands over the use of the company’s surgical robot, the da Vinci, but a recent FDA report did not seem terribly incriminating of the device’s design or manufacture.
FDA announced Nov. 8 that it was “aware of an increase in the number of medical device reports” associated with computer-assisted surgical systems, stating that the majority of the reports the agency received “were of device malfunctions,” including “component breakage, mechanical problems and image/display issues.”
On the other hand, FDA also said that much of the up-tick in reports of injuries and deaths associated with the device may be due to “increased publicity resulting from product recalls, media coverage, and litigation.” The agency went as far as to say that adverse event reports “can contain incomplete, inaccurate, duplicative, and unverified information,” and that the mere filing of a report “does not necessarily indicate a faulty or defective medical device.”
Somehow one doubts seriously whether the trial bar will be even slightly put off by the news. One also wonders when some brave surgeon will admit he or she screwed up, and that it wasn’t the device’s fault at all.
Ah, doctors and lawyers. Amazing.
Aghast over Avandia
And finally, we note that FDA has withdrawn its restrictions on Avandia. FDA stated in its Nov. 25 announcement that the data from the Record trial “showed no elevated risk of heart attack or death in patients being treated with Avandia when compared to standard-of-care diabetes drugs.” FDA stated further that the data “do not confirm” the reports of a greater risk of heart attacks as described by Steve Nissen and Kathy Wolski in their study appearing in NEJM in 2007.
This is actually two tales. One tale is that of a medical stampede, not toward a drug or device, but away from a drug or device. Ironically, the molecular entity behind Avandia went off patent last year, so the news comes just in time for generics makers to cash in.
The second tale is that despite the fact that Nissen was clearly mistaken, he went full bore with a conspiracy theory argument in the Wall Street Journal earlier this year when FDA announced it would hold an advisory committee hearing on the drug. A conspiracy of common sense, one supposes, is no less a conspiracy.