Is LipiScan a gizmo?
Scanner to Find Fatty Deposits in Vessels Is Approved
By Barnaby Feder
The New York Times
April 26, 2008
Federal regulators have approved the sale of a new laser scanning system intended to locate fatty deposits in blood vessel walls that are thought to cause heart attacks.
Lipid pools may be anywhere in an artery wall, not just where a blockage has formed from the buildup of plaque. Researchers are unsure whether stenting the pools might reduce heart attack risk, but many believe that inadvertently covering only part of a pool probably increases the risk of rupture.
But some researchers say the whole concept of trying to find and treat lipid pools with devices is a waste of time and money. The pools, they say, are a symptom of arterial disease that affects all of the heart’s arteries and indeed the whole circulatory system. They favor efforts to use drugs and lifestyle changes to reduce concentrations of the potentially dangerous lipids throughout the body.
InfraRdDx said its catheter, which emits near-infrared laser light inside the artery and forms an image from how much is absorbed, could produce a fuller picture of the contents and dimensions of lipids in the vessel walls. The company’s product, the LipiScan Coronary Imaging System, consists of a $150,000 computer console that analyzes and displays the data gathered by the LipiScan laser catheter, which costs $2,400 and can be used only once.
http://www.nytimes.com/2008/04/26/business/26plaque.html?scp=1&sq=LipiScan&st=nyt
And…
Gizmo Idolatry
By Bruce Leff, M.D. and Thomas E. Finucane, M.D.
JAMA
April 16, 2008
That utilization varies widely by region for several devices and procedures, with no better clinical outcomes in high-use regions, provides strong indirect evidence that gizmo idolatry exists and affects clinical practice.
Common Sense Appeal
Many gizmos make so much sense, in the absence of evidence or even the presence of evidence to the contrary, that their value or utility is persuasive prima facie. For example, if coronary artery occlusion causes myocardial infarction, opening the occlusions postinfarction makes sense. If coronary artery bypass graft surgery has significant morbidity and mortality, perhaps stents are the solution. If bare metal stents develop thrombosis, drug-eluting stents can reasonably be expected to be better. The above reasoning proceeds despite evidence that angiographically defined coronary stenosis is a poor predictor of subsequent occlusion and infarction in patients with stable angina. The face value and common sense appeal of such interventions contribute to their widespread diffusion, more rapidly than evidence alone could justify.
What to Do?
In the medical marketplace, some combination of avarice, hucksterism, credulity, genuine need, and gizmo idolatry impart considerable momentum to the early and unconsidered use of many unproven technologies. A multitiered strategy will be required to combat this phenomenon. Recognition of gizmo idolatry is a critical first step in educating consumers, both clinicians and patients, to be circumspect rather than enthusiastic and to seek evidence about the effectiveness of any medical technology. Tort reform may help reduce defensive medicine–induced gizmo idolatry. Wennberg et al have proposed reforms to the Medicare system to reduce, among other things, the use of supply sensitive services, sometimes a manifestation of gizmo idolatry. Their proposal includes (1) promoting health care organizational structures that foster effective care delivery, (2) detailed strategies to improve the quality of patient-physician decisions regarding treatments in which patient preference should play a role, (3) the promotion of more conservative practice styles, and (4) the establishment of Comprehensive Centers for Medical Excellence to implement these changes.
Conclusion
Gizmo idolatry describes the willingness to accept, in fact to prefer, unproven, technologically oriented medical measures. Several forces contribute to and encourage this tendency. Great burdens may result. Clinicians, patients, payers, and policy makers should be mindful of the urge to use gizmos. Purveyors should proceed responsibly, limiting promotional efforts until data about meaningful benefit to patients are developed. Payers should be stringent in their decisions to cover expensive and unproven treatments. Clinicians and patients should resist the clamor for the new and fancy. Finally, all stakeholders should encourage and reward diligent bedside care for all who need it.
http://jama.ama-assn.org/cgi/content/full/299/15/1830
<3>Comment:
By Don McCanne, MD
Think of how often a medical technology firm has suggested simple, inexpensive clinical management of a condition that would obviate the need to use their very expensive technology. Never? Yet those supporting market financing of our health care system insist that it encourages technological advances which provide higher quality care at lower costs. What we are receiving instead is much more expensive care, often of dubious value.
Technological firms develop products with the primary goal of making a lot of money - a whole lot of money. Their intention is that the results of their research would provide them with products that provide significant benefit to patients. That may not always turn out to be true, but if they can just get their products on the market then they can hope that the “common sense of gizmo idolatry” will drive the success of their innovations.
Other nations place limits on gizmo medicine while encouraging clearly beneficial high-tech services. Opponents of reform frequently criticize these limits as “government rationing” of health care. But is it really rationing to decline to pay for expensive interventions with highly dubious, unproven benefit? Whether paying a premium to an insurance company or paying a tax to a public insurance program, most of us would not want our funds wasted on these often detrimental excesses.
Remember that Antonio Egas Moniz received the Nobel Prize in 1949 for developing the leucotome - a retractable wire loop gizmo that cut the frontal lobes off of the brain. In our enlightened age, we should demand more than gizmos from the technology firms. If we had a national health program, we would have control of what the firms seek - the money to pay for their gizmos. Then maybe they would get it right.