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    <recommendedItem id="20100101_19_3240"
                     title="JAMA Editor to Step Down in 2011"
                     score="0.013"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/Ethics/tb/21999?impressionId=1283457920023"
                     
      &lt;p&gt;After more than 10 years leading the &lt;em&gt;Journal of the American Medical Association&lt;/em&gt;, editor-in-chief Catherine D. DeAngelis, MD, MPH, has announced plans to leave the post next June.&lt;/p&gt;
&lt;p&gt;A statement issued by the American Medical Association&apos;s &lt;em&gt;JAMA&lt;/em&gt; and &lt;em&gt;Archives&lt;/em&gt; journal group said DeAngelis would return to Johns Hopkins University in Baltimore where she will develop &quot;a Center for Professionalism in Medicine and the Related Professions, including nursing, public health, business and law.&quot;&lt;/p&gt;
&lt;p&gt;Before stepping into the &lt;em&gt;JAMA&lt;/em&gt; editorship, DeAngelis was vice dean for academic affairs and faculty at Hopkins.&lt;/p&gt;
&lt;p&gt;In her tenure at &lt;em&gt;JAMA&lt;/em&gt;, DeAngelis has advocated increasingly detailed conflict-of-interest disclosures for authors of medical journal articles  --  not only at &lt;em&gt;JAMA&lt;/em&gt; but in all publications.&lt;/p&gt;
&lt;p&gt;The statement noted that she has &quot;encouraged other editors to agree to a requirement for all clinical trials to be registered as a condition of publication and to strengthen conflict of interest guidelines,&quot; working through the International Committee of Medical Journal Editors.&lt;/p&gt;
&lt;p&gt;She also recently instituted a policy requiring an independent statistical review for all reports on industry-sponsored clinical trials published in &lt;em&gt;JAMA&lt;/em&gt;. &quot;No other journal has this stringent requirement to ensure the integrity of data,&quot; the statement boasted.&lt;/p&gt;
&lt;p&gt;&quot;Cathy DeAngelis has made a tremendous contribution to the profession of medicine through her leadership as Editor-in-Chief of &lt;em&gt;JAMA&lt;/em&gt;,&quot; said her boss, AMA chief executive Michael D. Maves, MD, MBA, in the statement. &quot;&lt;em&gt;JAMA&lt;/em&gt;&apos;s reputation for quality and integrity is known throughout the world.&quot;&lt;/p&gt;
&lt;p&gt;A search committee headed by Ronald G. Evens, MD, of Washington University in St. Louis, will identify candidates to replace DeAngelis. The AMA said it expects to have a new editor in place on July 1, 2011.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_3238"
                     title="Allergan Settles Civil and Criminal Charges"
                     score="0.013"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/Ethics/tb/21994?impressionId=1283457920023"
                     
      &lt;p&gt;Botox manufacturer Allergan will pay $375 million after pleading guilty to a misdemeanor misbranding charge related to off-label use of the cosmetic drug, a statement on the company&apos;s website said.&lt;/p&gt;
&lt;p&gt;In addition to the fine, the company agreed to pay $225 million to settle civil claims raised against it by the Department of Justice.&lt;/p&gt;
&lt;p&gt;The manufacturer came under criminal investigation from 2000 to 2005. The misbranding charge alleges that, during that time, the drug labeling did not contain complete directions for intended use, which included off-label uses for headache, pain, spasticity, and juvenile cerebral palsy.&lt;/p&gt;
&lt;p&gt;&quot;Under the Government&apos;s view, a use that the FDA has not approved (i.e., an &apos;off-label&apos; use) may be deemed &apos;intended&apos; based on written or oral statements made by the manufacturer,&quot; Allergan noted in the statement, adding that the company agreed that its marketing of the drug during the five years in question did result in those off-label uses.&lt;/p&gt;
&lt;p&gt;The drug was approved for use in treatment of flexor muscle spasms in the elbow, wrist, and fingers in adult patients in March. (See &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/18917&quot; mce_href=&quot;http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/18917&quot; target=&quot;_blank&quot;&gt;FDA Okays Botox Use in Elbow, Wrist, Muscle Spasms&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;Allergan filed for approval of onabotulinumtoxin A&apos;s use as a treatment for chronic migraine in 2008, but the results of that application are still pending. The company also is conducting phase III trials regarding use in patients with neurogenic and idiopathic overactive bladder, the prepared statement said.&lt;/p&gt;
&lt;p&gt;As part of the company&apos;s settlement, Allergan has entered a corporate integrity agreement that allows the company to keep its current compliance program at the cost of being subject to additional monitoring, adhering to new written standards, and engaging in auditing, training, education, reporting, independent and third-party review, and disclosure over a five-year period.&lt;/p&gt;
&lt;p&gt;Allergan is located in Irvine, Calif.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_3196"
                     title="ESC: Bone Marrow Cells May Help Heal Hearts (CME/CE)"
                     score="0.012"
                     href="http://www.medpagetoday.com/MeetingCoverage/ESCCongress/tb/21935?impressionId=1283457920023"
                     
      &lt;p&gt;STOCKHOLM  --  Injecting autologous bone marrow stem cells directly into the hearts of patients with chronic heart failure appears to improve ventricular performance, quality of life, and survival, according to an open-label, nonrandomized study.&lt;/p&gt;
&lt;p&gt;Benefits of the stem cell treatment were apparent within three months  --  and persisted for up to five years of follow-up, Bodo-Eckehard Strauer, of Heinrich Heine University of D&amp;#252;sseldorf, Germany, reported at the European Society of Cardiology Congress here.&lt;/p&gt;
&lt;p&gt;Patients who did not receive a stem cell infusion and remained on optimal medical therapy continued to deteriorate throughout the follow-up period.&lt;/p&gt;
&lt;p&gt;There were no side effects, Strauer said in a &quot;Hot Line&quot; session.&lt;/p&gt;
&lt;p&gt;The findings were reported earlier this year in the &lt;em&gt;European Journal of Heart Failure&lt;/em&gt;  --  a journal of the ESC  --  which led the society to bar Strauer from submitting abstracts for two years. Presenting previously-published data broke the rules for &quot;Hot Line&quot; data.&lt;/p&gt;
&lt;p&gt;Strauer said at a press briefing that patients with more severe heart failure seem to fare better from the stem cell treatment.&lt;/p&gt;
&lt;p&gt;&quot;This therapy has almost no risk. It can only be beneficial in patients. So, in my opinion, it has real clinical importance for the treatment of heart failure,&quot; he said.&lt;/p&gt;
&lt;p&gt;Rob Califf, MD, vice chancellor for research at Duke University, highlighted the limitations of the study in his comments to &lt;em&gt;MedPage Today&lt;/em&gt;:&lt;/p&gt;
&lt;p&gt;&quot;God gave us two gifts for doing clinical research  --  blinding and randomization,&quot; Califf said in an interview. &quot;If you have done neither, your data are interesting but not definitive.&quot;&lt;/p&gt;
&lt;p&gt;Strauer and his colleagues initially approached 391 patients with chronic heart failure resulting from an acute MI to participate in the study  --  191 agreed to receive an autologous bone marrow stem cell infusion, and 200 declined but agreed to participate as controls. The average period since patients experienced an MI was 8.5 years.&lt;/p&gt;
&lt;p&gt;Although not randomized, the two groups had similar characteristics at baseline.&lt;/p&gt;
&lt;p&gt;Mean left ventricular ejection fraction was 29.5% in the treatment group and 36.1% in the control group, but the difference was not statistically significant.&lt;/p&gt;
&lt;p&gt;All patients continued to receive optimal medical therapy.&lt;/p&gt;
&lt;p&gt;For the bone marrow cell infusion, the researchers harvested stem cells from the patients&apos; iliac crest. Mononuclear cells were isolated and rinsed with heparinized saline.&lt;/p&gt;
&lt;p&gt;An average of 66 million stem cells per patient were infused into the infarct-related artery via an angioplasty balloon catheter. Inflation of the balloon simulated an ischemic condition, which prevented back-flow of the cells and provided time for cell migration to the infarct area.&lt;/p&gt;
&lt;p&gt;At the three-month follow-up, there was significant improvement in left ventricular performance in the treatment group, reflected by improved cardiac index (by 22%), peak oxygen uptake (by 11%), and oxygen pulse (by 6.3%) (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 for all).&lt;/p&gt;
&lt;p&gt;Exercise capacity increased by 15.4% from baseline, and left ventricular ejection fraction improved from 29.4% at baseline to 36% at three months (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01 for both).&lt;/p&gt;
&lt;p&gt;Both end-diastolic and end-systolic volume decreased from baseline in the treatment group (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 for both).&lt;/p&gt;
&lt;p&gt;There were gains in quality of life as well, with the mean New York Heart Association (NYHA) class dropping from 3.22 to 2.25 (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0167). In the control group, NYHA worsened from 3.06 to 3.5.&lt;/p&gt;
&lt;p&gt;The benefits in the treatment group persisted through one and five years.&lt;/p&gt;
&lt;p&gt;The control group continued to deteriorate through the follow-up points.&lt;/p&gt;
&lt;p&gt;Survival was better in the treatment group than in the control group. Through follow-up, 0.75% of the stem cell-treated patients died each year compared with 3.68% per year among controls (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01).&lt;/p&gt;
&lt;p&gt;&quot;The reason [for the mortality reduction] may be twofold; namely, a decrease in pump failure and a decrease in severe cardiac arrhythmias,&quot; Strauer and his colleagues wrote in their paper.&lt;/p&gt;
&lt;p&gt;Commenting after Strauer&apos;s presentation at the meeting, Francisco Fernandez-Aviles, MD, PhD, of the Hospital General Universitario Gregorio Mara&amp;#241;&amp;#243;n in Madrid, noted the study&apos;s limitations stemming from the open-label nonrandomized design.&lt;/p&gt;
&lt;p&gt;&quot;But it is the largest trial comparing bone marrow cells versus optimal conventional therapy in patients with heart failure due to healed myocardial infarction,&quot; added Fernandez-Aviles, who highlighted many of the positive findings from the study.&lt;/p&gt;
&lt;p&gt;He said that certain steps should be taken before conducting large-scale clinical trials of the stem cell treatment.&lt;/p&gt;
&lt;p&gt;&quot;Translational, randomized, double-blinded, mechanistic studies are necessary to confirm these results, to further elucidate mechanisms, to identify the subgroups of patients with the highest benefit, and to compare different cells and different methods of delivery,&quot; Fernandez-Aviles said.&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;Strauer reported that he had no conflicts of interest.&lt;/p&gt;&lt;p&gt;Califf disclosed that in his position he oversees research funded by most pharmaceutical companies.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_3168"
                     title="Lab Tests Confirm Source of Salmonella in Eggs"
                     score="0.011"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/PublicHealth/tb/21897?impressionId=1283457920023"
                     
      &lt;p&gt;Test results from environmental samples at Wright County Egg  --  one of two related companies believed to have supplied &lt;em&gt;Salmonella&lt;/em&gt;-contaminated eggs now under nationwide recall  --  showed strains of the bacteria with the same DNA fingerprint seen in clinical isolates, FDA officials said.&lt;/p&gt;
&lt;p&gt;Chicken feed at facilities supplying Iowa-based Wright County Egg and Hillandale Farms also tested positive for &lt;em&gt;Salmonella enteritidis&lt;/em&gt; with the same genomic fingerprint, officials told reporters during a telephone briefing.&lt;/p&gt;
&lt;p&gt;&quot;Feed and feed ingredients perhaps were the sources, but maybe not the only sources,&quot; said Sherri McGarry of the FDA&apos;s food safety division.&lt;/p&gt;
&lt;p&gt;She noted that investigators had taken many more samples for which test results were not yet available.&lt;/p&gt;
&lt;p&gt;Jeff Farrar, DVM, PhD, MPH, associate commissioner of food safety at FDA, said the investigation still hadn&apos;t determined how &lt;em&gt;Salmonella&lt;/em&gt; bacteria got into the chicken feed, though rodent feces are the usual source in such situations.&lt;/p&gt;
&lt;p&gt;Farrar defended the government&apos;s response to the contamination, which has been criticized as too slow.&lt;/p&gt;
&lt;p&gt;&quot;We have to strike a balance between being timely and being accurate,&quot; he said, noting that the FDA requested that Wright County Egg and Hillandale Farms initiate the recall before lab results had confirmed that the companies&apos; eggs were the source of the outbreak.&lt;/p&gt;
&lt;p&gt;Christopher Braden, MD, of the CDC&apos;s foodborne diseases unit, said 2,403 &lt;em&gt;Salmonella enteritidis&lt;/em&gt; illnesses confirmed with the same DNA fingerprint had been reported from May 1 to Aug. 25.&lt;/p&gt;
&lt;p&gt;He emphasized that many of these probably were not related to the contaminated eggs, while other case reports would not have yet made their way to the CDC.&lt;/p&gt;
&lt;p&gt;Braden said 933 case reports of &lt;em&gt;Salmonella &lt;/em&gt;would have been expected during the same period, on the basis of averages seen in previous years.&lt;/p&gt;
&lt;p&gt;Since the CDC&apos;s last summary issued last week, no new clusters of illnesses and no reports of deaths associated with the outbreak had been received, Braden added.&lt;/p&gt;
&lt;p&gt;He also reported what he called &quot;good news&quot;  --  that no clusters of illnesses in nursing homes had been seen yet, which is important because the elderly are particularly vulnerable to &lt;em&gt;Salmonella&lt;/em&gt; illness.&lt;/p&gt;
&lt;p&gt;Moreover, he added, disease clusters traced to restaurants and other gatherings seen to date have all been small.&lt;/p&gt;
&lt;p&gt;Nevertheless, Braden said, the current outbreak was the largest ever reported for &lt;em&gt;Salmonella&lt;/em&gt;. The previous record for a &lt;em&gt;Salmonella &lt;/em&gt;outbreak occurred in 1994 from ice cream containing contaminated eggs  --  but that outbreak had fewer than 800 cases.&lt;/p&gt;
&lt;p&gt;More than half a billion eggs sold under 35 brands are now included in the recall.&lt;/p&gt;
&lt;p&gt;Farrar repeated a theme struck earlier in the week by FDA Commissioner Margaret Hamburg, MD  --  that enhanced powers for the FDA to regulate food production could have been helpful in containing the current outbreak.&lt;/p&gt;
&lt;p&gt;Legislation passed by the House of Representatives last year to strengthen the FDA&apos;s authority has languished in the Senate, though movement is now expected when senators return from their August holiday.&lt;/p&gt;
&lt;p&gt;Farrar said several aspects of the legislation &quot;could have sped up the investigation.&quot;&lt;/p&gt;
&lt;p&gt;Specifically, he said, the bill would let the FDA implement rules to allow retail foods to be traced quickly to their sources and would require that food producers open their records to FDA inspectors. It would also allow the FDA to order recalls.&lt;/p&gt;
&lt;p&gt;Currently, the agency can only request that companies voluntarily provide records and initiate recalls. Farrar said the egg companies had cooperated in the current investigation.&lt;/p&gt;
&lt;p&gt;Nevertheless, he asserted that the outbreak probe could have moved even faster if the FDA could have put muscle behind its requests.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_3161"
                     title="Docs&apos; Religion Tied to End-of-Life Care (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/Ethics/tb/21889?impressionId=1283457920023"
                     
      &lt;p&gt;The religious beliefs of physicians who treat patients at the end of life appear to influence clinical decision-making, a British survey showed.&lt;/p&gt;
&lt;p&gt;Physicians in the U.K. who reported being very or extremely religious were less likely to endorse certain end-of-life decisions, including continuous deep sedation and initiation of treatment that would be expected to shorten life, Clive Seale, PhD, of Queen Mary, University of London, reported online in &lt;em&gt;BMJ&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;They were also less likely to report discussing such options with patients or to support the legalization of euthanasia.&lt;/p&gt;
&lt;p&gt;&quot;One potential response to the findings about the influence of religious faith is to suggest, as others have done, that religious doctors disclose their moral objections to certain procedures to patients so that patients can choose other doctors if they wish,&quot; Seale wrote.&lt;/p&gt;
&lt;p&gt;However, he continued, &quot;It is equally plausible to argue that nonreligious doctors should confess their predilections to their patients.&quot;&lt;/p&gt;
&lt;p&gt;But regardless of religious faith, he concluded, &quot;it would seem advisable that doctors become more aware of how broader sets of values, such as those associated with religiosity or a nonreligious outlook, may enter into their decision-making in end-of-life care.&quot;&lt;/p&gt;
&lt;p&gt;Seale mailed surveys to 8,857 British general practitioners, neurologists, elderly care specialists, palliative care specialists, and physicians from &quot;other hospital&quot; specialities; 42.1% responded.&lt;/p&gt;
&lt;p&gt;Compared with respondents to the British Social Attitudes survey of the U.K. general population, the physician respondents were less likely to be Christian (51.6% versus 71.6%), but more likely to be Buddhist, Hindu, Jewish, or Muslim (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001 for all).&lt;/p&gt;
&lt;p&gt;Although ethnicity was unrelated, in general, to end-of-life decision-making, degree of religiosity did appear to influence it.&lt;/p&gt;
&lt;p&gt;In multivariate analyses, physicians who reported being very or extremely nonreligious reported higher rates of using continuous deep sedation (OR 1.45, 95% CI 1.02 to 2.06), making a decision involving some intention to hasten the end of life (OR 1.83, 95% CI 1.35 to 2.48), and supporting the legalization of euthanasia (OR 5.47, 95% CI 4.04 to 7.40) compared with those who held strong religious beliefs.&lt;/p&gt;
&lt;p&gt;Nonreligious physicians also were more likely to report having discussions about treatments that were expected to shorten life (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0005).&lt;/p&gt;
&lt;p&gt;&quot;This is similar to the finding from a U.S. study, which found more religious doctors to be less likely to feel they should disclose information about procedures to which they objected on moral grounds (birth control for adolescents, abortion, and &apos;terminal sedation&apos; in dying),&quot; Seale wrote.&lt;/p&gt;
&lt;p&gt;A physician&apos;s specialty was associated with end-of-life decision-making, as well.&lt;/p&gt;
&lt;p&gt;With the exception of physicians who identified their specialty as palliative care, specialties were more likely to report making a decision expected to shorten life (ORs ranging from 6.46 for those who care for the elderly to 9.64 for &quot;other hospital&quot; specialities) and supporting the legalization of assisted dying (ORs ranging from 2.66 for those who care for the elderly to 4.45 for &quot;other hospital&quot; specialities) (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0005 for all).&lt;/p&gt;
&lt;p&gt;Seale acknowledged that the study was limited by the low response rate and the reliance on retrospective recall and responses to fixed-choice questions.&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 and advised by a group including representatives of the funding bodies, including the National Council for Palliative Care, Age Concern, the Motor Neurone Disease Association, the Multiple Sclerosis Society, Help the Hospices, Macmillan Cancer Support, and Sue Ryder Care.&lt;/p&gt;&lt;p&gt;Seale reported that he had no conflicts of interest.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&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>
