The Heart Rhythm Society yesterday finalized its recommendations for reforming policies and guidances of implantable heart devices. Most notably, it suggested FDA stop using the word “recall” in public communications about problems with heart devices, on the theory that consumers believe that a “recalled” device must be removed immediately, which is rarely ever the case. Yesterday FDA issued a statement supporting much of what the society said, including the expansion of its cardiac advisory panel’s duties into evaluating postmarket safety and effectiveness issues. But it did not say whether it would drop the “recall” lingo. It should, but only if terminology that appropriately identifies the gravity of the situation can be agreed upon.
Is it possible that one day doctors will perform surgery in space? French physicians seem to think so, as a five-man team operated on a patient in nearly weightless conditions yesterday. The Associated Press reports that the procedure is part of the European Space Agency’s project to develop Earth-guided surgical space robots. Lasting eight minutes, doctors removed a cyst from a man in 22-second intervals. While the concept of space surgery might be exciting to some people, it’s way too expensive to justify its use in the future. Aside from the costs to develop the technology, chartering such a flight to perform the procedure would cost the equivalent of nearly $38,000 U.S. dollars, reports the U.K. Times Online.
The Kaiser Family Foundation released a report yesterday that some will find shocking. It found that the average cost of a family insurance plan is growing twice as fast as inflation, and has doubled since 1999. This is likely to lead to more calls to reduce healthcare costs. But David Leonhardt’s column in today’s New York Times puts things in a more reasonable perspective. Yes, healthcare costs used to be cheap half a century ago, but back then no one expected much from healthcare, nor for it to make much of an impact on longevity. But today’s expensive healthcare, including new medical devices, does have a significant impact on longevity. Of course waste does exist in the system, and we should do our best to eliminate it. But innovation costs money. Would we trade those costs for a shorter lifespan?
Yes, that’s billion, with a “b.” Johnson & Johnson is seeking $5.5 billion in damages from Abbott and Boston Scientific related to its failed Guidant acquisition, reports Reuters News. J&J had an agreement to buy Guidant that the latter broke in order to take a richer deal from Boston Scientific. The suit, filed in federal court in New York City, alleges that Guidant leaked confidential information about its deal to Abbott, which passed it on to Boston Scientific, who used the knowledge to win the battle for Guidant. Boston Scientific ended up spinning off Guidant’s stent business to Abbott.
Leslie Norwalk, deputy CMS administrator, will take over the top job at CMS on an acting basis, reports CQ.com (registration required). Herb Kuhn, head of the agency’s Center for Medicare Management, will move into the number-two position. The moves follow the departure of Mark McClellan, announced earlier this month. Both Norwalk and Kuhn have been mentioned as potential permanent successors to McClellan. Either would be a fine choice, as the agency needs continuity as it works to implement sweeping changes introduced under McClellan’s watch.
Today’s Boston Globe has a piece praising a technology that caught our eye recently, too: the VeinViewer, a device that helps locate hard-to-find veins. Many of us have, or know someone who has, veins that don’t present themselves easily when it comes time for an injection or to draw blood. This condition causes pain and discomfort. The VeinViewer, made by Luminetx Corp. (Memphis) and marketed by Diomed (Andover, MA), uses near-infrared light to produce a “vein map” on the skin. About 30 vein care centers so far are using the device, which went on the market in May. Expect patient demand to cause that number to climb.
FDA is holding a meeting on Oct. 25 in Gaithersburg, MD to collect public input on whether unique identification systems, such as bar codes, should be required for medical devices. Registration, including signups for those who want to speak at the meeting, is already open. It is crucial that industry present a strong case for how a non-burdensome unique device identification system should look. It’s unlikely that FDA will pass on the idea entirely, given recent safety issues.
Boston Scientific says sales of drug-eluting stents and implantable cardioverter-defibrillators are slowing, which will cause the firm to miss Wall Street analysts’ earnings expectations for the third quarter, according to the Boston Globe. Third-quarter earnings will be around $2 billion, short of Wall Street’s projected $2.2 billion. Doctors are slightly shifting away from implanting drug-eluting stents and ICDs. Safety concerns may be a factor.
The controversy over biomedical conflicts of interest between doctors and companies continued at a Cleveland Clinic conference yesterday. This relationship is necessary, but it shouldn’t cause the financial interest of doctors to get in the way of patient care, advised medical experts. While the issue has increased with the rapid pace of medical innovation, Philip Pizzo, Stanford University’s medical dean, said the key is to manage the conflicts, not try to eliminate them. The Associated Press also reports that as of October 1, Stanford University is prohibiting doctors that work at its hospitals from accepting any gifts in efforts to “eliminate corporate influence from medical decisions.” It’s not likely that this debate will end anytime soon, considering many doctors need to work with companies, from serving as consultants to being trained on a device’s use.
The United States Senate Committee on Health, Education, Labor and Pensions voted today to move the nomination of Andrew von Eschenbach to be FDA commissioner to the Senate floor, Bloomberg News reports. The matter is now before the full Senate. The timetable for a confirmation vote is uncertain as two senators have vowed to block it until certain issues are addressed.
