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<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_467"
                     title="FDA Unveils New Safety Plan for Medical Imaging"
                     score="0.012"
                     href="http://www.medpagetoday.com/Radiology/DiagnosticRadiology/tb/18398?impressionId=1265805208523"
                     
      &lt;p&gt;WASHINGTON  --  The Food and Drug Administration (FDA) says it wants to issue new safety requirements for manufacturers of computed tomography (CT) and fluoroscopic devices to reduce unnecessary radiation from medical imaging.&lt;/p&gt;
&lt;p&gt;The FDA&apos;s plan focuses on three procedures with high radiation doses: CT, nuclear medicine studies, and fluoroscopy. These are the greatest contributors to total radiation exposure within the U.S. population, the FDA said. That&apos;s because they require much higher radiation doses than other radiographic procedures, such as standard X-rays, dental X-rays, and mammography.&lt;/p&gt;
&lt;p&gt;&quot;The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years,&quot; Jeffrey Shuren, MD, director of the FDA&apos;s Center for Devices and Radiological Health, said in a prepared statement. &quot;The goal of FDA&apos;s initiative is to support the benefits associated with medical imaging while minimizing the risks.&quot;&lt;/p&gt;
&lt;p&gt;While the three procedures have led to early diagnosis of disease, they expose patients to ionizing radiation that may increase lifetime cancer risk  --  although there is debate within the medical community about the extent of the danger.&lt;/p&gt;
&lt;p&gt;Radiologist Joseph Schoepf, MD, director of Cardiovascular Imaging at the Medical University of South Carolina, lauded the FDA&apos;s initiative and said it would restore the public&apos;s trust in imaging.&lt;/p&gt;
&lt;p&gt;&quot;It is important to note, however, that an increase in cancer mortality [from radiation] has not been observed,&quot; he added. &quot;On the contrary, cancer mortality has dramatically decreased over the past decades, in step with increased utilization of medical imaging.&quot;&lt;/p&gt;
&lt;p&gt;The &lt;em&gt;Archives of Internal Medicine &lt;/em&gt;recently published results from two studies indicating that &lt;a href=&quot;http://www.medpagetoday.com/Radiology/DiagnosticRadiology/17530&quot; mce_href=&quot;http://www.medpagetoday.com/Radiology/DiagnosticRadiology/17530&quot; target=&quot;_blank&quot; title=&quot;CT&amp;#8200;Scans&amp;#8200;May&amp;#8200;Deliver&amp;#8200;Higher-than-Expected&amp;#8200;Radiation&amp;#8200;Doses&quot;&gt;CT scans deliver much higher doses of radiation &lt;/a&gt;than previously thought. The FDA has noted that a patient would have to get 400 standard chest X-rays to be exposed to the same level of radiation as just one CT abdomen scan.&lt;/p&gt;
&lt;p&gt;In an accompanying editorial, the journal&apos;s editor, Rita Redberg, MD, wrote that the studies &quot;make us question if we have gotten carried away in our enthusiasm&quot; for CT.&lt;/p&gt;
&lt;p&gt;It&apos;s becoming clear, she said, that the large doses of radiation from CT scans will lead to additional cancers, which must be taken into account when physicians consider CT for their patients.&lt;/p&gt;
&lt;p&gt;By working with healthcare providers and other federal agencies, the FDA says it hopes to promote safer use of medical imaging and increase patient awareness of their radiation exposure. Part of that involves pushing providers to justify their radiation procedures and optimize the radiation dose in each one.&lt;/p&gt;
&lt;p&gt;&lt;span&gt;Schoepf, who serves on several American College of Radiology committees that discuss the proper used of various imaging procedures, approved of the FDA&apos;s goal but cautioned against restrictions that would hinder clinicians.&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;&quot;There is indeed a need for enhanced transparency, better patient education, more dialogue between patients and their healthcare providers, and increased involvement of the patient in the decision process leading up to an imaging study,&quot; Schoepf said.&lt;/p&gt;
&lt;p&gt;&lt;span&gt;&quot;What is often forgotten in this discussion is that serious injury or death, resulting from missing a potentially life-threatening diagnosis if no imaging is performed, is a much greater, more imminent, and very real risk.&quot;&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;In its statement, the FDA said it wants to boost efforts to develop at least one national registry of radiation doses that will capture information from a variety of imaging studies that can be used to establish benchmarks for healthcare facilities to use with patients.&lt;/p&gt;


 &lt;p&gt;Donald Frush, MD, a radiologist at Duke Medical Center and expert in CT radiation doses in children, said that radiation doses for CT examination vary widely, depending on the size of the patient and the body area scanned, among other things.&lt;/p&gt;
    &lt;p&gt;&quot;However, sometimes this variation is not necessary, and the dose may be excessive,&quot; Frush said.&lt;/p&gt;

&lt;p&gt;The ACR launched a similar registry about a year ago, according to spokesman Shawn Farley. The database is intended as a guide so a radiologist can quickly see how levels of radiation delivered in other practices and hospitals compare to what he or she is delivering.&lt;/p&gt;
&lt;p&gt;&quot;Now that the FDA has come out in favor of doing that, we&apos;re hoping that will put a little more weight behind the process and make more facilities want to take part in this,&quot; Farley told &lt;em&gt;MedPage Today. &lt;/em&gt;&lt;/p&gt;


 &lt;p&gt;Schoepf noted that European governments already require a permanent record of radiation exposure for each patient.&lt;/p&gt;
    &lt;p&gt;As a result, manufacturers of radiation equipment, most of whom sell their products in Europe, already have that capability, he said. So it shouldn&apos;t be difficult to implement the same standard in the U.S.&lt;/p&gt;
    &lt;p&gt;&quot;Radiation exposure should be no secret,&quot; Schoepf said.&lt;/p&gt;


&lt;p&gt;The FDA will hold a public meeting March 30 and 31 to hear comments on what types of safety requirements to establish for manufacturers of CT and fluoroscopic devices. Requirements might include: &lt;ul&gt; &lt;li&gt;That the radiation device display, record, and report equipment settings and radiation dose&lt;/li&gt; &lt;li&gt;Alerting users when the dose exceeds the optimal dose for most patients&lt;/li&gt; &lt;li&gt;Increased training for users&lt;/li&gt; &lt;li&gt;Ability to capture and transmit radiation dose information to a patient&apos;s electronic medical record in addition to national dose registries &lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;&lt;em&gt;This article was developed in collaboration with ABC News. &lt;/em&gt;&lt;img src=&quot;http://www.medpagetoday.com/upload/2009/10/1/14357_1.jpg&quot; mce_src=&quot;http://www.medpagetoday.com/upload/2009/10/1/14357_1.jpg&quot; alt=&quot;&quot;&gt;&lt;/p&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_458"
                     title="Calcium Scoring Misses 20% of CAD Cases (CME/CE)"
                     score="0.012"
                     href="http://www.medpagetoday.com/Cardiology/AcuteCoronarySyndrome/tb/18387?impressionId=1265805208523"
                     
      &lt;p&gt;Contrary to guidelines, the absence of coronary artery calcium doesn&apos;t rule out coronary artery disease in symptomatic patients, researchers found in a new study.&lt;/p&gt;
&lt;p&gt;In a multicenter clinical trial, 19% of patients with a coronary calcium score of 0 had stenosis of at least 50% in one or more coronary artery segments, according to Carlos E. Rochitte, MD, of the University of S&amp;#227;o Paulo, Brazil, and colleagues.&lt;/p&gt;
&lt;p&gt;Likewise, 20% of vessels seen to be totally occluded on revascularization had no calcium on scans, they reported in the Feb. 16 issue of the &lt;em&gt; Journal of the American College of Cardiology&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;&quot;The absence of coronary calcification should not be used as a gatekeeper and should not prevent a symptomatic patient from undergoing angiography,&quot; the researchers wrote.&lt;/p&gt;
&lt;p&gt;Currently, American Heart Association/American College of Cardiology guidelines suggest that excluding measurable coronary calcium could serve as an effective filter for sending patients on to invasive testing or admitting them.&lt;/p&gt;
&lt;p&gt;One systematic review of 18 studies had indicated that a zero calcium score had a negative predictive value of 93% for stenosis and a positive predictive value of 68% in symptomatic patients.&lt;/p&gt;
&lt;p&gt;However, in Rochitte&apos;s trial  --  CORE64 (Coronary Evaluation Using Multi-Detector Spiral Computed Tomography Angiography Using 64 Detectors)  --  the negative predictive value of a coronary calcium score of 0 was 68%, while the positive predictive value was 81%.&lt;/p&gt;
&lt;p&gt;Overall sensitivity to predict the absence of significant (at least 50%) stenosis was 45%, while specificity was 91%.&lt;/p&gt;
&lt;p&gt;&quot;This apparent lack of predictive value of a calcium scan should be enough to give a clinician pause,&quot; Rita F. Redberg, MD, of the University of California San Francisco, wrote in an accompanying editorial.&lt;/p&gt;
&lt;p&gt;Whatever the reason for the discrepancy, neither the trial nor the review provided any information on how coronary calcium scans add incrementally to traditional predictors of coronary artery disease, such as clinical assessment and stress testing, she said. Nor would she rule out their use entirely for patients with chest pain.&lt;/p&gt;
&lt;p&gt;&quot;Given the significant &lt;a href=&quot;http://www.medpagetoday.com/Cardiology/AcuteCoronarySyndrome/12732&quot; mce_href=&quot;http://www.medpagetoday.com/Cardiology/AcuteCoronarySyndrome/12732&quot; target=&quot;_blank&quot;&gt;radiation risks&lt;/a&gt; of coronary artery calcium scans, however, clinicians must use extreme caution when ordering such scans,&quot; Redberg cautioned.&lt;/p&gt;
&lt;p&gt;The prospective &lt;a href=&quot;http://www.medpagetoday.com/Radiology/DiagnosticRadiology/11927&quot; mce_href=&quot;http://www.medpagetoday.com/Radiology/DiagnosticRadiology/11927&quot; target=&quot;_blank&quot;&gt;CORE64 study&lt;/a&gt; was originally designed to compare diagnostic performance of CT and invasive angiography in symptomatic patients with suspected coronary artery disease. But it also included a coronary calcium scan up to 30 days prior to conventional angiography.&lt;/p&gt;
&lt;p&gt;Of the 291 patients included in the calcium score analysis (73% male, mean age 59.3), 56% had at least 50% coronary stenosis by conventional angiography and 45% had at least 70% stenosis.&lt;/p&gt;
&lt;p&gt;Calcium score only weakly correlated with the highest degree of coronary stenosis found in a patient. Its ability to predict presence of significant lesions was &quot;moderate&quot; (area under the receiver-operating characteristic curve 0.77, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).&lt;/p&gt;
&lt;p&gt;A non-zero score was associated with 8.1-fold likelihood of having at least 50% coronary stenosis (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001) after adjusting for age, sex, hypertension, dyslipidemia, family history of premature heart disease, diabetes, race, and hospitalization.&lt;/p&gt;
&lt;p&gt;Among the 100 patients who went on to revascularization within 30 days of angiography, 13% had a coronary calcium score of 0, 25% had a score of 1 to 10, and 44% had a score over 10 (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.001 for trend).&lt;/p&gt;
&lt;p&gt;The fact that significant coronary artery disease occurred in the absence of calcification in almost 20% of patients should not be surprising, since coronary calcification is thought to occur late in the atherosclerotic process, while obstruction can occur earlier, Redberg asserted.&lt;/p&gt;
&lt;p&gt;The researchers also cautioned that the results would not apply to asymptomatic patients with intermediate risk for events, a group in which a score of 0 has been consistently shown to indicate low risk.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was supported by grants from Toshiba Medical Systems, the Doris Duke Charitable Foundation, the National Heart, Lung, and Blood Institute, the National Institute on Aging, and the Donald W. Reynolds Foundation.&lt;/p&gt;&lt;p&gt;Rochitte reported no conflicts of interest. Co-authors reported financial relationships with Toshiba Medical Systems, Bayer, Schering, GE Healthcare, Bracco, Bristol-Myers Squibb, sanofi-aventis, and Vital Images.&lt;/p&gt;&lt;p&gt;Redberg provided no information on conflicts of interest.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_449"
                     title="FDA Okays Statin for Primary Prevention"
                     score="0.012"
                     href="http://www.medpagetoday.com/InfectiousDisease/PublicHealth/tb/18380?impressionId=1265805208523"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has approved rosuvastatin (Crestor) for primary prevention of cardiovascular disease, making it the first statin to receive this indication.&lt;/p&gt;
&lt;p&gt;The new labeling, recommended by an FDA advisory panel late last year, also marks the first time that a drug label will include an indication based on the biomarker highly-sensitive C-reactive protein, an inflammatory marker.&lt;/p&gt;
&lt;p&gt;The new indication would be for men 50 or older and women 60 or older who have fasting LDL of less than 130 mg/dL, a highly-sensitive CRP of 2.0 mg/L or greater, triglycerides of less than 500 mg/dL, and no prior history of heart attack or stroke, or coronary heart disease risk.&lt;/p&gt;
&lt;p&gt;The basis for the new labeling was the JUPITER trial, a randomized, placebo-controlled trial of 17,802 men and women with a mean age of 66 and no history of atherosclerosis. All participants had LDL of less than 130 mg/dL and a highly-sensitive C-reactive protein concentration of 2 mg/L or higher.&lt;/p&gt;
&lt;p&gt;Patients were randomized to 20 mg of rosuvastatin for 1.9 years, which reduced median LDL cholesterol to 55 mg/dL, down from a median of 108 mg/dL at baseline. The corresponding relative reduction in the rate of MI, stroke, arterial revascularization, or cardiovascular death was 44% (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.00001).&lt;/p&gt;
&lt;p&gt;The number needed to treat to avoid one cardiovascular event was 25.&lt;/p&gt;
&lt;p&gt;Those results, according to Melvyn Rubenfire, MD, of the University of Michigan, were a &quot;home run for JUPITER,&quot; but it is not clear whether the results would be the same with another statin.&lt;/p&gt;
&lt;p&gt;And there were some risks associated with rosuvastatin, including 13 deaths due to gastrointestinal disorders in the rosuvastatin arm, and 18 patients reported experiencing a &quot;confused state&quot; while taking the drug.&lt;/p&gt;
&lt;p&gt;The most troubling adverse event, however, was an uptick in investigator-reported, new onset diabetes mellitus in the treatment arm, 2.8% versus 2.5%, for a hazard ratio of 1.27 (95% CI 1.05 to 1.53, &lt;em&gt;P&lt;/em&gt;=0.015).&lt;/p&gt;
&lt;p&gt;Rosuvastatin in marketed by AstraZeneca, which also sponsored the JUPITER trial.&lt;/p&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_400"
                     title="Fractured Evidence: Spine Repair Debate Heats Up"
                     score="0.01"
                     href="http://www.medpagetoday.com/Surgery/Orthopedics/tb/18303?impressionId=1265805208523"
                     
      &lt;p&gt;Hundreds of thousands have benefited from vertebroplasty, advocates insist. They say the minimally-invasive procedure has freed them from hospital beds and dependence on intravenous narcotics.&lt;/p&gt;
&lt;p&gt;Spine physicians swear that inserting a large-gauge needle into fractured vertebrae and injecting a cement compound to stabilize the bone hastens healing and helps relieve the often-crippling pain of compression fractures brought on by osteoporosis or metastatic disease.&lt;/p&gt;
&lt;p&gt;But two recently-published, randomized controlled trials  --  the gold standard of evidence-based medicine  --  say otherwise. As far as disability and pain relief were concerned, they found that vertebroplasty for osteoporotic vertebral compression fractures was no better than a sham procedure.&lt;/p&gt;
&lt;p&gt;Publication of the results triggered an outraged backlash from radiologists, for whom vertebroplasty is a bread-and-butter operation. The entire specialist community lambasted the studies  --  statistically and methodologically.&lt;/p&gt;
&lt;p&gt;But experts in evidence-based medicine argue that when profits are on the line, it&apos;s easy to be persuaded that studies are flawed.&lt;/p&gt;
&lt;p&gt;So the debate rages, with radiologists citing case after case of success, arguing that patients with the worst fractures will have no treatment alternatives if the nation&apos;s third-party payers  --  Medicare and the insurance companies&lt;strong&gt; -&lt;/strong&gt;- refuse to pay for the procedure anymore.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;The Studies&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Both randomized, controlled studies were published last August in the &lt;em&gt;New England Journal of Medicine&lt;/em&gt;. They involved a combined total of about 200 patients. Each found that vertebroplasty did not yield significantly better results in terms of disability or short-term pain relief than sham procedures for patients with this type of vertebral fracture.&lt;/p&gt;
&lt;p&gt;In an e-mail to &lt;em&gt;MedPage Today&lt;/em&gt;, the author of one study, Rachelle Buchbinder, PhD, of Monash University in Australia, suggested that the research showed the procedure was ineffective.&lt;/p&gt;
&lt;p&gt;&quot;Based upon the results of both trials I don&apos;t think that this treatment should be offered in routine care,&quot; she declared.&lt;/p&gt;
&lt;p&gt;But the leader of the other trial, David Kallmes, MD, of the Mayo Clinic in Rochester, Minn., offered a different interpretation. He said the studies have been largely misunderstood by the trials&apos; critics&lt;strong&gt;.&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;&quot;I&apos;ve been practicing for 15 years and had strong confidence that the procedure was effective, and that&apos;s exactly what we showed,&quot; he said in a telephone interview.&lt;/p&gt;
&lt;p&gt;Mean baseline pain intensity on a 10-point scale was 6.9 in the vertebroplasty group and 7.2 in the sham-operated group in his trial, which had 131 patients. One month later, these scores had declined to 3.9 and 4.6, respectively.&lt;/p&gt;
&lt;p&gt;Kallmes said this degree of pain reduction with vertebroplasty &quot;exactly reproduces our prior experience.&quot; He vehemently denied that the findings were &quot;discordant&quot; with prior experience, as two statements from the Society of Interventional Radiology (SIR) put it.&lt;/p&gt;
&lt;p&gt;&quot;I don&apos;t know what they&apos;re talking about,&quot; Kallmes said. &quot;It is concordant.&quot;&lt;/p&gt;
&lt;p&gt;He said the real surprise was the effectiveness of the sham procedure, which should be the focus of follow-up investigations.&lt;/p&gt;
&lt;p&gt;It involved inserting needles into the spinal column and injecting short-acting painkillers such as lidocaine, as was also done with vertebroplasty prior to inserting needles into the fractured vertebrae and injecting the cement.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;The Flaws&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Critics of the two studies cite a laundry list of complaints: too few patients, failure to meet enrollment, inclusion of patients with milder degrees of pain and disability than those usually treated.&lt;/p&gt;
&lt;p&gt;In a November commentary from SIR, issued in conjunction with &lt;em&gt;NEJM&apos;s &lt;/em&gt;publication of letters critical of the studies, J. Kevin McGraw, MD, of Riverside Radiology and Interventional Associates in Columbus, Ohio, highlighted the fact that Kallmes&apos; study originally called for 250 patients.&lt;/p&gt;
&lt;p&gt;Only 131 enrolled, and the vast majority  --  1,682 of 1,813 screened  --  were excluded, &quot;introducing significant selection bias into the study,&quot; he complained.&lt;/p&gt;
&lt;p&gt;McGraw also pointed out that Kallmes&apos; group didn&apos;t use screening MRI to ensure that a fracture was the cause of the patient&apos;s pain.&lt;/p&gt;
&lt;p&gt;In addition, he did some additional statistical noodling and found that if one additional patient had reported a favorable response in the vertebroplasty group, the &lt;em&gt;P&lt;/em&gt;-value would be 0.04, rather than a nonsignificant 0.06. Likewise, if one more patient had an unfavorable response in control group, the association&apos;s&lt;em&gt; P&lt;/em&gt;-value would become significant.&lt;/p&gt;
&lt;p&gt;Finally, in the crossover part of the trial, McGraw highlighted that 12% of patients in the vertebroplasty arm elected the sham procedure, while 43% of those who got the sham went for the real thing.&lt;/p&gt;
&lt;p&gt;&quot;The tremendous crossover rate speaks for some obvious benefit of vertebroplasty over sham and is worthy of a future adequately powered analysis to evaluate,&quot; McGraw wrote.&lt;/p&gt;
&lt;p&gt;As for the Buchbinder trial, McGraw said it was convoluted by selection bias, since two-thirds of patients came from a single center and their procedures were performed by a single radiologist. The commentary also criticizes the volume of cement injected into vertebrae as lower than normal.&lt;/p&gt;
&lt;p&gt;Similarly, the North American Spine Society issued a critique of patient selection criteria and outcome measures, and questioned whether the sham treatment was actually an active therapy. The statement suggested that dry needling might be a more appropriate control.&lt;/p&gt;
&lt;p&gt;One of the letters published in &lt;em&gt;NEJM&lt;/em&gt; also criticized the protocol requirement that patients undergo four weeks of medical therapy prior to enrollment in the trial. During that time, some fractures would have already healed, &quot;resulting in a study on healed fractures,&quot; a group of Australian physicians wrote.&lt;/p&gt;
&lt;p&gt;SIR president Brian F. Stainken, MD, took issue with the fact that patients with the most pain  --  typically older, osteoporotic women  --  weren&apos;t represented.&lt;/p&gt;
&lt;p&gt;McGraw said these patients would be the least likely to agree to be in a randomized trial with a 50% chance of receiving the sham treatment.&lt;/p&gt;
&lt;p&gt;&quot;Most people in severe pain won&apos;t enroll,&quot; Stainken said. &quot;At some level, research design has to take reality into consideration.&quot;&lt;/p&gt;
&lt;p&gt;&quot;The population with low-grade pain, that&apos;s the population these papers focused on,&quot; he continued. &quot;It&apos;s not clear what the right solution is for this group. But I think the contribution of these [two &lt;em&gt;NEJM&lt;/em&gt; studies] may be toward that.&quot;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;On the Defense&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Kallmes, however, responded that there was no difference in baseline pain scores between patients entering the study and those considered eligible but refusing to participate.&lt;/p&gt;
&lt;p&gt;He also told &lt;em&gt;MedPage Today&lt;/em&gt; that he and colleagues &quot;enrolled patients that are very similar to those treated around the world.&quot;&lt;/p&gt;
&lt;p&gt;&quot;These studies were by far, by far, the best studies ever done,&quot; Kallmes declared.&lt;/p&gt;
&lt;p&gt;&quot;I have full confidence that if we had shown something different, that is, if we had found the procedure was more effective than placebo, people would have embraced it and said they were great studies,&quot; he continued.&lt;/p&gt;
&lt;p&gt;&quot;They would have said, &apos;Look at it, they were prospective, randomized, blinded, near 100% follow-up.&apos; They would have been held up as the paragon for how to do studies in the future  --  if we had reinforced people&apos;s preconceived notions.&quot;&lt;/p&gt;
&lt;p&gt;Richard Deyo, MD, MPH, professor of evidence-based medicine at Oregon Health &amp;amp; Science University in Portland and deputy editor of &lt;em&gt;Spine,&lt;/em&gt; told &lt;em&gt;MedPage Today&lt;/em&gt; that the studies are the best evidence to date regarding the effectiveness of vertebroplasty in these patients.&lt;/p&gt;
&lt;p&gt;&quot;No study is perfect, and these are not perfect, but I do think they&apos;re the best we have,&quot; Deyo said.&lt;/p&gt;
&lt;p&gt;Deyo said there was some validity to complaints that the studies enrolled too few patients, although both trials were adequately powered to detect a difference in pain reduction.&lt;/p&gt;
&lt;p&gt;&quot;If the benefit of this treatment were as enormous as many of the advocates argue,&quot; he said, &quot;then it would take a much smaller study to demonstrate a huge benefit.&quot;&lt;/p&gt;
&lt;p&gt;On the other hand, the studies were too small to evaluate the effects among various patient subgroups.&lt;/p&gt;
&lt;p&gt;Kallmes also criticized the societies&apos; press releases, charging they were written by some &quot;who haven&apos;t read the studies carefully.&quot;&lt;/p&gt;
&lt;p&gt;&quot;The societies are in a great position,&quot; he said. &quot;They have thought leaders that they can partner with to move the science forward. Moving the science forward is not done by sending out press releases.&quot;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Radiologists&apos; Concerns&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;SIR&apos;s reaction may not be surprising, given that radiologists are so vested in vertebroplasty. Medicare will pay physicians from $522 to $554 for a procedure on one vertebra performed in a hospital or outpatient surgery clinic  --  or more than $2,000 if it&apos;s conducted in the physician&apos;s office.&lt;/p&gt;
&lt;p&gt;The number of annual procedures varies from office to office, and radiologists provide varying estimates. McGraw said he performs about 150 vertebroplasties annually, and Stainken said the procedure accounts for about 20% of radiologists&apos; procedures, although that estimate &quot;may be a little high.&quot;&lt;/p&gt;

&lt;p&gt;One of the radiologists&apos; main concerns is that insurance companies will use the trials to justify ending coverage of vertebroplasty for osteoporotic spinal fractures.&lt;/p&gt;
&lt;p&gt;But insurers started playing that card long before the &lt;em&gt;NEJM&lt;/em&gt; trials were published.&lt;/p&gt;
&lt;p&gt;In a 2008 report, the Technology Evaluation Center of the Blue Cross and Blue Shield Association (BCBSA) concluded that neither vertebroplasty nor the related kyphoplasty  --  which restores compression-fractured vertebrae to their normal size with a balloon before the cement injection  --  had been demonstrated to be any better at improving net health outcomes than medical treatments.&lt;/p&gt;
&lt;p&gt;That same year, Wellpoint, the insurance giant with 35 million members, announced plans to classify both procedures &quot;investigational.&quot; That prompted a letter from SIR imploring the company to reconsider.&lt;/p&gt;
&lt;p&gt;Another spine physician, Christopher Bono, MD, of Brigham &amp;amp; Women&apos;s Hospital in Boston, told &lt;em&gt;MedPage Today &lt;/em&gt;that Aetna was also reconsidering coverage for vertebroplasty following the &lt;em&gt;NEJM&lt;/em&gt; publications.&lt;/p&gt;

&lt;p&gt;He said that he believed the firms would not end coverage entirely, but policies would be more restrictive.&lt;/p&gt;
&lt;p&gt;&quot;My gut sense is that payers are going to be much more selective in who they will pay for [regarding vertebroplasty],&quot; Bono said. &quot;They will ask for certain documentation and many more criteria than they did in the past.&quot;&lt;/p&gt;
&lt;p&gt;McGraw worries that seniors will be &quot;denied coverage when they are in the twilight of their lives and could possibly have long-standing suffering&quot; that &quot;could lead to their demise.&quot;&lt;/p&gt;
&lt;p&gt;Stainken said there&apos;s &quot;clear, unambiguous data that prolonged bed rest is the beginning of the cycle of decline for these patients. The key is to be able to do everything we can to ... keep these patients ambulatory and avoid that whole scenario.&quot;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Change is Hard&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Deyo said money may partly explain the reluctance of physicians who perform vertebroplasties to scale back their use of the procedure.&lt;/p&gt;
&lt;p&gt;&quot;There are people who are making a living doing this, and you don&apos;t easily change what you do for a living,&quot; Deyo said.&lt;/p&gt;
&lt;p&gt;The man credited with coining the term &quot;evidence-based medicine&quot; agreed.&lt;/p&gt;
&lt;p&gt;&quot;If you are making money from a procedure, it is very easy to persuade yourself that new evidence that the procedure is ineffective is in some way flawed or limited to allow you to continue to make money on the procedure,&quot; Gordon Guyatt, MD, of McMaster University in Hamilton, Ontario, told &lt;em&gt;MedPage Today.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;&quot;When we have opinions and beliefs, we are very resistant to new evidence.&quot;&lt;/p&gt;
&lt;p&gt;Kallmes, too, said there are psychological reasons for not accepting the results: &quot;People just don&apos;t want to be convinced. They don&apos;t want to change their preconceived notions.&quot;&lt;/p&gt;
&lt;p&gt;&quot;They have this anecdotal experience,&quot; he added, &quot;but I can tell them anecdotes of miraculous results with the placebo. So if they do this same study themselves, they may find the same thing I found.&quot;&lt;/p&gt;
&lt;p&gt;Still, McGraw and Bono insisted the studies were too flawed to serve as the evidence base for clinical practice.&lt;/p&gt;
&lt;p&gt;&quot;Before we make these two studies the Holy Grail of evidentiary medicine with regard to vertebroplasty, we need to have larger trials,&quot; McGraw said.&lt;/p&gt;
&lt;p&gt;Bono said evidence-based medicine, properly implemented, has three components: reviewing and applying the best data, &quot;but also incorporating surgeon experience and patient preference.&quot;&lt;/p&gt;
&lt;p&gt;&quot;If you are just using the first, and I&apos;m a strong advocate for using data and literature and references, I think you&apos;re doing a disservice,&quot; he said. &quot;And then if you are misinterpreting the data or twisting the data or slanting the data, and eliminating the other two, you are really abusing the word evidence-based medicine.&quot;&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Outcomes&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;So, will vertebroplasty go the way of other procedures that seemed to work clinically, but bombed in trials, such as knee arthroscopy for osteoarthritis?&lt;/p&gt;
&lt;p&gt;SIR is awaiting the results of VERTOS II, a 200-patient Dutch trial comparing vertebroplasty with conservative therapy in patients with painful, osteoporotic vertebral compression fractures. And Stainken called for large trials that will address several of the methodology issues raised with the &lt;em&gt;NEJM &lt;/em&gt;reports.&lt;/p&gt;
&lt;p&gt;With regard to the potential placebo effect, Kallmes said he has nearly completed a 20-patient, open-label study of a procedure like that used as the sham in the randomized trial  --  a spinal injection of short-acting painkillers.&lt;/p&gt;
&lt;p&gt;Also in the works is a comparative trial of vertebroplasty and balloon kyphoplasty, he said.&lt;/p&gt;
&lt;p&gt;Stainken said he has heard from colleagues who said they had slowed down or stopped doing the procedures after the studies were published, &quot;which is not unreasonable  --  to think it through and understand the situation.&quot;&lt;/p&gt;
&lt;p&gt;However, most have resumed performing the procedure, and demand for it continues, he added.&lt;/p&gt;
&lt;p&gt;Aman Patel, MD, an associate professor of radiology and neurosurgery at Mount Sinai School of Medicine in New York City, said he and his colleagues have not changed their practice since learning of the studies&apos; findings.&lt;/p&gt;
&lt;p&gt;However, he has started telling patients about the findings from the &lt;em&gt;NEJM&lt;/em&gt; studies so they can be fully informed of the existing evidence about the risks and benefits of vertebroplasty.&lt;/p&gt;
&lt;p&gt;&quot;I firmly believe this procedure benefits some, if not many, patients,&quot; Patel said.&lt;/p&gt;
&lt;p&gt;McGraw said he tells patients about the trials, but he also tells patients who he thinks would benefit from vertebroplasty that he doesn&apos;t believe the findings apply to them.&lt;/p&gt;
&lt;p&gt;He said one patient had initially declined the procedure after talking it over. &quot;That patient called me up a week later to proceed with vertebroplasty,&quot; he said.&lt;/p&gt;
&lt;p&gt;Even if the findings don&apos;t change the way spine doctors use vertebroplasty in the short term, Deyo suspects the results will lead to fewer procedures in the long run.&lt;/p&gt;
&lt;p&gt;Guyatt and Deyo predicted that eventually, a critical mass of evidence would be assembled  --  assuming future randomized studies replicate these results  --  that would convince even the most steadfast adherents.&lt;/p&gt;
&lt;p&gt;Also, the &lt;em&gt;NEJM&lt;/em&gt; studies could have an immediate effect in promoting more research by increasing the level of doubt about the procedure, Deyo said: &quot;I don&apos;t think we have the final word here.&quot;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;Deyo, Guyatt, Patel, and Stainken reported having no relevant conflicts of interest.&lt;/p&gt;&lt;p&gt;Bono reported financial relationships other than research funding with Life Spine, Depuy, Medtronic, and Stryker, and research funding from Archus Orthopedics and Synthes Spine. He was lead author of the North American Spine Society&apos;s critique of the two randomized trials published in the &lt;em&gt;New England Journal of Medicine&lt;/em&gt;.&lt;/p&gt;&lt;p&gt;McGraw has had relationships with Cardinal Spine, Arthrocare Spine, and Hatch Medical.&lt;/p&gt;&lt;p&gt;Kallmes reported relationships with ArthroCare, Stryker, Cardinal, and Cook.&lt;/p&gt;&lt;p&gt;Buchbinder reported receiving research funding from Cook.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_361"
                     title="Hidden Dangers of Herbal Meds Reviewed"
                     score="0.008"
                     href="http://www.medpagetoday.com/PrimaryCare/AlternativeMedicine/tb/18244?impressionId=1265805208523"
                     
      Herbal medicines are not always the harmless nostrums that many patients and even some physicians think, but may actually contribute to cardiovascular morbidity and mortality, researchers warned in a review covering 44 years of research into the subject.&lt;br&gt;
&lt;br&gt;Many such products, including aloe vera, ginkgo biloba, ginseng, and green tea, can interact with conventional cardiovascular drugs and lead to serious adverse reactions, according to Arshad Jahangir, MD, of the Mayo Clinic in Scottsdale, Ariz., and two other Mayo physicians.&lt;br&gt;
&lt;br&gt;&quot;There is a clear need for better public and physician understanding of herbal products through health education, early detection and management of herbal toxicities, scientific scrutiny of their use, and research on their safety and effectiveness,&quot; they wrote in the Feb. 9 &lt;em&gt;Journal of the American College of Cardiology&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Jahangir and colleagues also called for increased regulation of such products, at least requiring manufacturers of herbal medicines to register with the FDA and provide evidence of good manufacturing practices.&lt;/p&gt;
&lt;p&gt;&quot;Some of these adverse drug reactions are preventable,&quot; Jahangir told &lt;em&gt;MedPage Today&lt;/em&gt; in a telephone interview. &quot;Simple things like taking a good history or giving that history and discussing these issues, probably we can avoid [such reactions].&quot;&lt;/p&gt;
&lt;p&gt;Other physicians contacted by &lt;em&gt;MedPage Today&lt;/em&gt; and ABC News agreed that the growth in popularity of herbal medicines poses problems for physicians and patients.&lt;/p&gt;
&lt;p&gt;&quot;Because these remedies are &apos;natural,&apos; their potential dangers are not considered the same way they would be if they were medication,&quot; commented Suzanne Steinbaum, MD, a cardiologist at Lenox Hill Hospital in New York City, in an e-mail.&lt;/p&gt;
&lt;p&gt;&quot;For many reasons, patients tend not to disclose to their doctors if they are taking herbal remedies, including fear that their doctors won&apos;t approve or they will be told to stop them,&quot; Steinbaum added. &quot;This lack of knowledge and full-disclosure, for some, might be a fatal omission.&quot;&lt;/p&gt;
&lt;p&gt;Jahangir and colleagues reviewed nearly 90 publications that have addressed herbal or complementary therapies and cardiovascular effects since 1966.&lt;/p&gt;
&lt;p&gt;Their &lt;em&gt;JACC&lt;/em&gt; article listed 15 common herbal medicines known to interact adversely with conventional cardiovascular drugs.&lt;/p&gt;
&lt;p&gt;In many cases, the herbal products compete with the regular medicines for the same drug-metabolizing cytochrome P450 enzymes, potentiating the latter&apos;s effects. In other cases, the herbal products have their own cardiovascular effects.&lt;/p&gt;
&lt;p&gt;Many physicians already know that grapefruit juice occupies the CYP3A4 enzyme, leading to slower-than-expected metabolism and, therefore, higher blood levels of a host of pharmaceuticals.&lt;/p&gt;
&lt;p&gt;These include the statins, calcium channel antagonists, several common anti-arrhythmic drugs, and the angiotensin receptor blocker irbesartan (Avapro), Jahangir and colleagues noted.&lt;/p&gt;
&lt;p&gt;Garlic is one of several common herbal remedies with specific cardiovascular effects in its own right (others include ginkgo biloba, ginseng, and saw palmetto). Garlic inhibits platelet aggregation and thus can lead to increased bleeding risks when combined with aspirin, clopidogrel (Plavix), or warfarin (Coumadin), the researchers noted.&lt;/p&gt;
&lt;p&gt;The Mayo group identified 10 herbal products that increase bleeding risks with anticoagulant and antiplatelet drugs, as well as 14 that can induce arrhythmias.&lt;/p&gt;
&lt;p&gt;In all, Jahangir and colleagues listed 27 herbal products that patients with cardiovascular diseases would do well to avoid. These include such common and harmless-seeming products as green tea, capsicum pepper, licorice, and kelp, as well as grapefruit juice and garlic.&lt;/p&gt;
&lt;p&gt;&quot;We need to check with our patients what type of products they are using, to identify these potential interactions,&quot; Jahangir told &lt;em&gt;MedPage Today&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;He cited the previously reported figure of 100,000 deaths annually from drug interactions, adding, &quot;We don&apos;t even know how many of these are due to use of compounds that we are not aware that our patients are taking.&quot;&lt;/p&gt;
&lt;p&gt;Jahangir said he was surprised, in preparing the review, at the scale of hebal medicine use in the U.S.&lt;/p&gt;
&lt;p&gt;He and his colleagues found data from the 1990s suggesting that more patients consult complementary and alternative medicine providers than regular physicians.&lt;/p&gt;
&lt;p&gt;The total annual out-of-pocket expenditure on complementary and alternative medicine services and products also was greater than for conventional physician services.&lt;/p&gt;
&lt;p&gt;&quot;The surprise for me was . . . how much people are willing to spend on a type of therapy which has not shown, in any scientific way, to be effective or safe,&quot; Jahangir said.&lt;/p&gt;
&lt;p&gt;He added that the trend may reflect shortcomings of the conventional medical system.&lt;/p&gt;
&lt;p&gt;&quot;What is the reason people are going there? Is it because there is some unmet type of need that we are not recognizing as practitioners of conventional medicine?&quot;&lt;/p&gt;
&lt;p&gt;Jahangir said it may be that physicians aren&apos;t spending enough time with patients to understand their true needs. He said it appears that, &quot;despite the advancement in our technology and new medicines, there is a demand for alternative therapies that is increasing.&quot;&lt;/p&gt;
&lt;p&gt;He recommended that, in addition to asking patients in detail about herbal and other alternative therapies they may be using, physicians should educate themselves on what these therapies purport to do and what is known about their real biological effects.&lt;/p&gt;
&lt;p&gt;The &lt;a href=&quot;http://nccam.nih.gov&quot; mce_href=&quot;http://nccam.nih.gov&quot; target=&quot;_blank&quot;&gt;National Center for Complementary and Alternative Medicine&lt;/a&gt; at the National Institutes of Health is a good starting point for such information, both for physicians and for patients, Jahangir said.&lt;/p&gt;
&lt;p&gt;Lenox Hill&apos;s Steinbaum said it was important that conventional physicians &quot;become more open-minded and accepting&quot; of alternative medicine, if only because so many of their patients are already practicing it.&lt;/p&gt;
&lt;p&gt;David Meyerson, MD, JD, a Johns Hopkins University cardiologist, told &lt;em&gt;MedPage Today&lt;/em&gt; and ABC News in an e-mail that he advises patients to limit their use of &quot;unstudied and unproven and FDA-unregulated herbal medications.&quot;&lt;/p&gt;
&lt;p&gt;&quot;It&apos;s unfortunately very big business, and potential drug interactions and potential harmful effects abound,&quot; he wrote.&lt;/p&gt;
&lt;p&gt;But another physician criticized the Mayo physicians&apos; emphasis on adverse effects in their review.&lt;/p&gt;
&lt;p&gt;&quot;For many of products listed, evidence for side effects seems to be minimal,&quot; Scott Grundy, MD, of the University of Texas Southwestern Medical Center in Dallas, argued in an e-mail.&lt;/p&gt;
&lt;p&gt;He agreed that the efficacy and safety of such drugs remains largely unproven, but added, &quot;It is mainly for these reasons that they cannot be recommended for use.&quot;&lt;/p&gt;
&lt;p&gt;Creating alarm about side effects &quot;may not be the appropriate way to discourage their use,&quot; Grundy said.&lt;/p&gt;
&lt;p&gt;&lt;em&gt;This article was developed in collaboration with ABC News. &lt;/em&gt;&lt;img src=&quot;http://www.medpagetoday.com/upload/2009/10/1/14357_1.jpg&quot; mce_src=&quot;http://www.medpagetoday.com/upload/2009/10/1/14357_1.jpg&quot; alt=&quot;&quot;&gt;&lt;/p&gt;
    </recommendedItem>
</recommendedContent>