A paper published in the February issue of Health Affairs — discussed at length in an article in the New York Times — contains the sort of blunt, plain-spoken language you seldom read in academic journals. The authors, who include some of the most prominent neuroscientists and ethicists in the world, warn that manufacturers are misusing the FDA’s humanitarian device exemption to promote deep brain stimulation as a “treatment” for obsessive compulsive disorder (OCD).
In fact, they make clear that deep brain stimulation is very much an experimental procedure. Research is still at an early stage, and the risks to patients are not well defined. When suffering is severe and no other treatment has provided relief, there is value in making available an intervention like deep brain stimulation. But misleading or biased information, no matter where it comes from, certainly undermines patients’ ability to calculate benefits and risks.
To enable deep brain stimulation, a surgeon must first implant electrodes in the brain and connect them to a pair of small electrical generators underneath the collarbone. Deep brain stimulation uses electricity to affect how brain signals are transmitted in particular areas of the brain. The image to the left, from the National Institute of Mental Health, shows how deep brain stimulation depends on the implantation of pulse generators below the collarbone and electrodes in the brain.
Specific concerns are raised by the article in Health Affairs (and in our own article on this topic last year in the Harvard Mental Health Letter). Read more »
The recurring narrative among health reformers is that hospitals that provide more care raise health costs, but don’t necessarily improve quality. This has lead to a backlash against so-called “aggressive” hospitals and doctors, with upcoming financial penalties to match. But the situation, as always, appears to be more nuanced than that.
In her column in the New York Times, Dr. Pauline Chen looks at one subset of patients who actually may benefit from aggressive care: Those who suffer surgical complications. The study,
found no difference in the rate of complications for aggressive and nonaggressive hospitals. But when they looked at all the patients who had complications and examined their outcomes, the researchers found that regardless of the urgency of their operations, those patients who were cared for at more aggressive hospitals were significantly more likely to survive their complications than those who had their operations at less aggressive hospitals.
In addition, the investigators found that characteristics associated with intensity of care treated surgical complications better:
… a hospital’s failure or success in treating surgical complications correlated consistently with factors that also characterized intensity of care — general expenditures, intensive care unit use and the total days of hospitalization — they found that benefits of this more aggressive care extended well beyond the time of the operation.
I constantly remind readers of this blog that more medicine isn’t necessarily better. The counter-intuitive findings from the Dartmouth Atlas study have been instructive in convincing patients that they are, in many cases, overtreated. Read more »
*This blog post was originally published at KevinMD.com*
If you’ve been watching Jeopardy! over the past couple days, you probably know that IBM’s highly-advanced artificial intelligence software, Watson, has been competing against Jeopardy!’s most successful contestants (and as of Tuesday night, took a commanding lead over the humans, despite having some trouble with United States geography).
Besides the amazing ability to power through “Daily Doubles” and answer random trivia in the form of a question, IBM researchers believe that Watson could revolutionize the healthcare industry. From diagnostics to informatics, Watson could quickly search through medical records, clinical documents, and research information for precise answers that would benefit both doctors and patients.
Check out the video below to see physicians explain how Watson’s technology could transform medicine.
Also watch the TED.com webcast of Dr. David Ferrucci (Principal Investigator of the DeepQA/Watson project at IBM), Dr. Herbert Chase (Professor of Clinical Medicine at Columbia University School of Physicians and Surgeons), and others discussing the Jeopardy! challenge and the impact the technology behind Watson could have on society.
One of the things that makes evaluating medical evidence difficult is knowing whether what’s being published actually reflects reality. Are the studies we read a good representation of scientific truth, or are they full of cherry-picked data that help sell drugs or skew policy decisions?
That question may sound like that of a paranoiac, but rest assured, it’s not. Researchers have worried about a “positive publication bias” for decades. The idea is that studies showing an effect of a particular drug or procedure are more likely to be published. In 2008, for example, a group of researchers published a New England Journal of Medicine study showing that nearly all — or 94 percent — of published studies of antidepressants used by the FDA to make approval decisions had positive results. But the researchers found that when the FDA included unpublished studies, only about half — or 51 percent — were positive.
A PLoS Medicine study published that same year found similar results for studies long after drugs were approved: Less than half — 43 percent — of studies used by the FDA to approve 90 drugs were published within five years of approval. It was those with positive results that were more likely in journals.
All of that can leave the impression that something may work better than it really does. And there is at least one powerful incentive for journals to publish positive studies: Drug and device makers are much more likely to buy reprints of such reports. Such reprints are highly lucrative for journals. Read more »
This was the Guest Blog at Scientific American on February 16th, 2011.
New wave of MRI-safe pacemakers set to ship to hospitals
This week Medtronic will begin shipping to hospitals in the United States the first pacemaker approved by the FDA as safe for most MRI scans. For consumers, it is a significant step in what is expected to be a wave of new MRI-compatible implanted cardiac devices.
But this is an example of one technology chasing another and the one being chased, the MRI scanner, is changing and is a step ahead of the new line of pacemakers. The pacemaker approved for U.S. distribution is Medtronic’s first-generation pacemaker with certain limitations, while its second-generation MRI-compatible pacemaker is already in use in Europe where approval for medical devices is not as demanding as it is in the U.S. So let’s check out what this is all about — what it means now for current and future heart patients and where it may be headed.
We are all born with a natural pacemaker that directs our heart to beat 60 to 100 times a minute at rest. The pacemaker is a little mass of muscle fibers the size and shape of an almond known medically as the sinoatrial node located in the right atrium, one of four chambers of the heart. The natural pacemaker can last a lifetime. Or it can become defective. And even if it keeps working normally, some point may not function well along the electrical pathway from the pacemaker to the heart’s ventricles which contract to force blood out to the body.
Millions of people in the world whose hearts beat too fast, too slow, or out of sync because their own pacemaker is not able to do the job right, follow their doctors’ recommendation to get an artificial pacemaker connected to their heart to direct its beating. The battery-run pacemaker in a titanium or titanium alloy case the size of a small cell phone, (why can’t it be the size of an almond?) is implanted in the upper left chest, just under the skin, with one or two insulated wire leads connecting to the heart. It can be programmed to run 24/7 or to only operate when the heart reaches a certain state of irregular beating. Read more »
*This blog post was originally published at HeartSense*
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