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    <recommendedItem id="20100101_19_340"
                     title="Week 30: Obama Lashes Back at GOP Days After State of the Union"
                     score="0.009"
                     href="http://www.medpagetoday.com/Washington-Watch/Reform/tb/18223?impressionId=1265795018621"
                     
      &lt;p&gt;WASHINGTON  --  President Barack Obama chided Republicans on Friday for portraying healthcare reform as a &quot;Bolshevik plot&quot; in which the president is &quot;doing all kinds of crazy stuff that&apos;s going to destroy America.&quot;&lt;/p&gt;
&lt;p&gt;The accusation came when Obama addressed House Republicans at their annual policy retreat, where he urged the GOP to back away from hyperbolic rhetoric on healthcare.&lt;/p&gt;
&lt;p&gt;&quot;All I&apos;m saying is we&apos;ve got to close the gap a little bit between the rhetoric and the reality,&quot; he said during a question-and-answer session following his speech.&lt;/p&gt;
&lt;p&gt;&quot;I&apos;m not suggesting that we&apos;re going to agree on everything, whether it&apos;s on healthcare or energy or what have you, but if the way these issues are being presented by the Republicans is that this is some wild-eyed plot to impose huge government in every aspect of our lives, what happens is you guys then don&apos;t have a lot of room to negotiate with me.&quot;&lt;/p&gt;
&lt;p&gt;&quot;You&apos;ve given yourselves very little room to work in a bipartisan fashion because what you&apos;ve been telling your constituents is, &apos;This guy&apos;s doing all kinds of crazy stuff that&apos;s going to destroy America.&apos;&quot;&lt;/p&gt;
&lt;p&gt;But he appreciates opposition, Obama told the crowd.&lt;/p&gt;
&lt;p&gt;&quot;I&apos;m a big believer not just in the loyalty of opposition but in its necessity,&quot; Obama said. &quot;It&apos;s only through the process of disagreement and debate that bad ideas get tossed out and good ideas get refined and made better.&quot;&lt;/p&gt;
&lt;p&gt;He told the Republicans that his healthcare reform plan incorporates a number of GOP ideas, including allowing people to purchase insurance across state lines.&lt;/p&gt;
&lt;p&gt;House Republican Leader John Boehner (R-Ohio) presented Obama with a binder of their party&apos;s solutions to the nation&apos;s problems.&lt;/p&gt;
&lt;p&gt;&quot;I&apos;ve read your legislation,&quot; Obama said. &quot;I take a look at this stuff. And the good ideas we take.&quot; But, he said, &quot;It can&apos;t be all or nothing, one way or the other.&quot;&lt;/p&gt;
&lt;p&gt;Following the address and the question-and-answer period, House Republicans held a press conference, in which they thanked the president for agreeing to hold a conversation with them on their turf.&lt;/p&gt;
&lt;p&gt;&quot;Let me say, House Republican leaders are grateful for the president of the United States&apos; willingness to come in a freewheeling and open environment and have a frank and honest conversation about the future of this country, said Rep. Mike Pence (R-Ind.).&lt;/p&gt;
&lt;p&gt;But, as Boehner pointed out, willingness to engage does not equate to bi-partisan lawmaking.&lt;/p&gt;
&lt;p&gt;&quot;The president has always been willing to work a little more closely with us, but, really, it&apos;s never translated into real action on the Hill,&quot; he told reporters.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;State of the Union &lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;The GOP retreat came just two days after Obama addressed the nation in his first &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/18182&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/18182&quot; target=&quot;_blank&quot; title=&quot;&apos;Do&amp;#8200;Not&amp;#8200;Walk&amp;#8200;Away&amp;#8200;from&amp;#8200;Reform,&apos;&amp;#8200;Obama&amp;#8200;Urges&amp;#8200;Congress&quot;&gt;State of the Union address.&lt;/a&gt; The address was short on healthcare specifics and lacked a blueprint for jump starting the stalled healthcare reform legislation.&lt;/p&gt;
&lt;p&gt;&quot;Here&apos;s what I ask of Congress, though: Do not walk away from reform,&quot; the president said Wednesday night.&lt;/p&gt;
&lt;p&gt;&quot;Not now. Not when we are so close. Let us find a way to come together and finish the job for the American people,&quot; he said, to a standing ovation from both Democrats and Republicans.&lt;/p&gt;
&lt;p&gt;The Jan. 19 &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/18053&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/18053&quot; target=&quot;_blank&quot; title=&quot;GOP&amp;#8200;Scores&amp;#8200;Win&amp;#8200;in&amp;#8200;Massachusetts&amp;#8200;Senate&amp;#8200;Race&quot;&gt;election&lt;/a&gt; of Massachusetts Republican Scott Brown to the U.S. Senate significantly altered the trajectory of healthcare reform. Now Democrats are regrouping, working on a strategy to pass reform legislation without a 60-vote majority in the Senate, and denying that there is any timeline for melding the measures passed by the &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/17679&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/17679&quot; target=&quot;_blank&quot; title=&quot;Senate&amp;#8200;Passes&amp;#8200;Healthcare&amp;#8200;Reform&quot;&gt;Senate&lt;/a&gt; and the &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/16847&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/16847&quot; target=&quot;_blank&quot; title=&quot;House&amp;#8200;Passes&amp;#8200;Healthcare&amp;#8200;Reform&quot;&gt;House&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Budget Due&lt;/p&gt;
&lt;p&gt;&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Although healthcare reform may be in flux, the president is looking ahead, and will release on Monday his proposed 2011 budget, in which he will outline proposed allocations for the Department of Health and Human Services, including the Food and Drug Administration, the Centers for Medicare and Medicaid Services, and the National Institutes of Health.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_200"
                     title="Debate Surges on Composite Endpoints"
                     score="-0.002"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/ClinicalTrials/tb/18046?impressionId=1265795018621"
                     
      &lt;p&gt;Composite endpoints can obscure the real findings of clinical trials, two researchers charged in a &lt;em&gt;JAMA&lt;/em&gt; commentary this week, but others who had led trials using such outcomes defended the practice.&lt;/p&gt;
&lt;p&gt;Composite endpoints  --  where a study&apos;s main outcome is a combination of two or more different types of events, such as death and nonfatal myocardial infarction  --  can serve useful purposes, George Tomlinson, PhD, and Allan S. Detsky, MD, PhD, both of the University of Toronto, wrote in the Jan. 20 &lt;em&gt;Journal of the American Medical Association&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;But the benefits of composite endpoints come with a price, they argued  --  confusion to physicians and patients.&lt;/p&gt;
&lt;p&gt;&quot;Clinicians want to know if all events in the composite outcome are affected equally by the intervention,&quot; Tomlinson and Detsky wrote.&lt;/p&gt;
&lt;p&gt;Physicians can usually find results for the endpoint&apos;s individual components, they acknowledged, but it may &quot;result in some confusion, because the component relative risks may have broad confidence intervals and differ widely, at times even extending in opposite directions.&quot;&lt;/p&gt;
&lt;p&gt;Moreover, the Toronto researchers argued, if readers must examine results of the individual components of the composite endpoint to grasp the study&apos;s clinical implications, it defeats the composite endpoint&apos;s original purpose.&lt;/p&gt;
&lt;p&gt;&quot;While [readers] were enticed by a trial performed according to rigorous principles and based on the primary composite outcome, once the results have been reported they find that their interest has been redirected to individual outcomes of questionable importance,&quot; Tomlinson and Detsky wrote.&lt;/p&gt;
&lt;p&gt;They acknowledged that composites may sometimes make clinical sense, or are necessary because no single outcome is a natural primary endpoint by itself. Another practical rationale is to reduce the number of patients necessary in a study to detect a significant treatment effect.&lt;/p&gt;
&lt;p&gt;For example, if an outcome is expected to occur at a 5% annual rate and the trial is planned to last five years, more than 2,500 patients are needed to establish a hazard ratio of 0.75 with &lt;em&gt;P&lt;/em&gt;&amp;lt;0.05, Tomlinson and Detsky noted.&lt;/p&gt;
&lt;p&gt;But if several outcomes can be combined into a composite endpoint that has an annual rate of 20%, fewer than 800 patients will provide adequate power.&lt;/p&gt;
&lt;p&gt;That&apos;s generally fine when the individual component events occur at approximately equal rates, are of similar seriousness, and change in the same way with treatment, but that is frequently not the case, Tomlinson and Detsky contended.&lt;/p&gt;
&lt;p&gt;Steven Nissen, MD, a Cleveland Clinic cardiologist, agreed in a phone interview with &lt;em&gt;MedPage Today&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Noting that composites of death, heart attack, and stroke are common in cardiovascular therapy trials, &quot;one would argue that all three of those outcomes are fairly grave [and] involve death or permanent injury,&quot; he said, and thus can be appropriate to combine into a single outcome.&lt;/p&gt;
&lt;p&gt;But, he added, &quot;what if the combination of endpoints is illogical, where you&apos;re combining grave endpoints with endpoints that are much less serious.&quot; In that case, the composite is much more difficult to interpret and may actually mislead readers about the study&apos;s true findings, Nissen suggested.&lt;/p&gt;
&lt;p&gt;&quot;Composite endpoints are a necessary evil, but they have to be thought through very carefully,&quot; he said.&lt;/p&gt;
&lt;p&gt;One trial with composites of serious and not-so-serious outcomes was reported last month at the American Society of Hematology meeting.&lt;/p&gt;
&lt;p&gt;Presented by Jeffrey Carson, MD, of the University of Medicine and Dentistry of New Jersey in New Brunswick, N.J., it tested different postoperative blood transfusion volumes. (See &lt;a href=&quot;http://www.medpagetoday.com/MeetingCoverage/ASHHematology/17418&quot; mce_href=&quot;http://www.medpagetoday.com/MeetingCoverage/ASHHematology/17418&quot; target=&quot;_blank&quot;&gt;ASH: Lower Threshold for Post-op Transfusion Proves Safe&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;Its primary outcome was a combination of death and walking ability, and a secondary endpoint was a composite of death, myocardial infarction, infection, congestive heart failure, stroke, and venous thromboembolism.&lt;/p&gt;
&lt;p&gt;In a recent phone interview with &lt;em&gt;MedPage Today&lt;/em&gt;, Carson said composites are frequently chosen to reduce the necessary sample size, but in his study the rationale was more about finding an outcome that best reflected the clinical issue.&lt;/p&gt;
&lt;p&gt;Including death alongside less serious outcomes such as inability to walk or infections was intended to capture the possibility that a transfusion regime might improve the lesser outcome but increase mortality.&lt;/p&gt;
&lt;p&gt;&quot;You wouldn&apos;t want to declare that, well, it improves your chances of walking and not consider its impact on death,&quot; Carson explained.&lt;/p&gt;
&lt;p&gt;Another study with a composite endpoint was a 2006 study of rosiglitazone (Avandia) called DREAM. Its primary endpoint combined death with incidence of new-onset diabetes. (See &lt;a href=&quot;http://www.medpagetoday.com/Endocrinology/Diabetes/4115&quot; mce_href=&quot;http://www.medpagetoday.com/Endocrinology/Diabetes/4115&quot; target=&quot;_blank&quot;&gt;EASD: Avandia Prevents Progression to Diabetes in High-Risk Patients&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;Tomlinson and Detsky held up DREAM in the very first paragraph of their &lt;em&gt;JAMA&lt;/em&gt; commentary as an example of a questionable composite endpoint.&lt;/p&gt;
&lt;p&gt;&quot;Death and diabetes are quite far apart in the spectrum of severity,&quot; they wrote, suggesting that clinicians would find the outcome  --  a 60% reduction in the two events  --  hard to interpret.&lt;/p&gt;
&lt;p&gt;&quot;Two questions arise,&quot; they wrote. &quot;Was there a 60% reduction in both death and diabetes? Are the two outcomes just as likely to occur?&quot;&lt;/p&gt;
&lt;p&gt;Nissen agreed that DREAM well illustrated the problems that can arise from composite endpoints.&lt;/p&gt;
&lt;p&gt;&quot;I do not like the situation where endpoints that have a great deal of difference in gravity and seriousness are combined,&quot; he told &lt;em&gt;MedPage Today&lt;/em&gt;. &quot;This was a great example.&quot;&lt;/p&gt;
&lt;p&gt;But the lead investigator on DREAM defended the composite outcome in a phone interview with &lt;em&gt;MedPage Today&lt;/em&gt;, insisting that sample size or other cost-based rationales never entered into the decision to use it.&lt;/p&gt;
&lt;p&gt;&quot;I&apos;ll quote from the paper,&quot; said Hertzel Gerstein, MD, of McMaster University in Hamilton, Ontario. &quot;It was to account for the possibility that diabetes might develop at a different rate in individuals who died than in individuals who survived. . . . It had nothing to do with any suggestion that the drug might prevent death. In fact, what we did in the DREAM trial, it was explicitly designed to [enroll] people at low risk of having serious outcomes including death.&quot;&lt;/p&gt;
&lt;p&gt;Gerstein continued, &quot;It was designed that way in order to be careful that we did not overestimate the benefit of the drug and provide the most conservative estimate of the benefit of the drug on diabetes prevention.&quot;&lt;/p&gt;
&lt;p&gt;Nissen, however, argued that composites chosen for legitimate scientific reasons are subject to misinterpretation when the results are published or submitted to regulators.&lt;/p&gt;
&lt;p&gt;Consider the composite of death, myocardial infarction, stroke, or hospitalization for unstable angina or revascularization, a common endpoint in registration trials for cardiovascular drugs, he said. Very often it&apos;s the hospitalizations that dominate the composite outcome, as they are far more common than the more serious events.&lt;/p&gt;
&lt;p&gt;&quot;When these companies go to the FDA, they often ask for a label related to the composite outcome. &apos;This drug is approved to reduce the risk of death, heart attack, stroke, and hospitalization for revascularization.&apos; Is that a good regulatory decision or a bad regulatory decision?&quot; Nissen asked.&lt;/p&gt;
&lt;p&gt;Jeffrey Carson said such composites are frequently criticized, but they can be reported in such a way as to minimize the chance of misinterpretation.&lt;/p&gt;
&lt;p&gt;&quot;It&apos;s likely that readmission to the hospital is the predominant reason for an event [in the composite] in studies of that sort,&quot; he said. &quot;You shouldn&apos;t say that it affects mortality, and you shouldn&apos;t say it affects myocardial infarction. What you should say is that it looks like the predominant effect here is on readmissions.&quot;&lt;/p&gt;
&lt;p&gt;Tomlinson and Detsky suggested that one way around this problem would be for authors and readers to assign weights to the various components of a composite outcome to reflect their clinical importance, &quot;similar to the way quality of life is measured.&quot;&lt;/p&gt;
&lt;p&gt;Alternatively, they wrote, when a composite outcome is driven by effects on the most numerous but least severe component, it should be understood to have shown an &quot;effect on surrogate outcomes and not definitive ones.&quot;&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_193"
                     title="Democratic Supermajority at Stake in Mass. Election"
                     score="-0.002"
                     href="http://www.medpagetoday.com/Washington-Watch/Reform/tb/18032?impressionId=1265795018621"
                     
      &lt;p&gt;WASHINGTON  --  As voters in Massachusetts cast ballots to elect a new U.S. senator, Democrats in Congress are scrambling to come up with a backup plan in case Republican Scott Brown beats Democrat Martha Coakley in today&apos;s election.&lt;/p&gt;
&lt;p&gt;If Brown takes the seat  --  left vacant after &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/15694&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/15694&quot; target=&quot;_blank&quot; title=&quot;Brain&amp;#8200;Tumor&amp;#8200;Fells&amp;#8200;Ted&amp;#8200;Kennedy&quot;&gt;Sen. Edward Kennedy died&lt;/a&gt; in August  --  the win would break the Democrat&apos;s filibuster-proof 60-seat supermajority. Although the &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/17679&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/17679&quot; target=&quot;_blank&quot; title=&quot;Senate&amp;#8200;Passes&amp;#8200;Healthcare&amp;#8200;Reform&quot;&gt;Senate has already passed&lt;/a&gt; a healthcare reform bill, in the typical course of events, the upper chamber would need to take a final vote on whatever measure results when its bill is combined with the &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/16847&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/16847&quot; target=&quot;_blank&quot; title=&quot;House&amp;#8200;Passes&amp;#8200;Healthcare&amp;#8200;Reform&quot;&gt;bill passed by the House&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;&lt;span class=&quot;mceItemHidden&quot;&gt;Coakley, who is the Massachusetts attorney general, and Brown, a state senator, were neck-and-neck in the polls when voting booths opened.&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;Another option would obviate a need for a second Senate vote by convincing members of the House to approve a version of the bill that closely mirrors what the Senate passed. That version could then go directly to the president&apos;s desk.&lt;/p&gt;
&lt;p&gt;Although the two bills are similar  --  and identical on some points  --  a few notable differences make it unlikely that members of the House would support a wholesale adoption of the Senate bill.&lt;/p&gt;
&lt;p&gt;For instance, the Senate bill is less restrictive about using federal funds for abortion, it doesn&apos;t contain a public insurance plan, and it doesn&apos;t exempt insurance companies from antitrust laws.&lt;/p&gt;
&lt;p&gt;At least one moderate Democrat  --  Rep. Bart Stupak (D-Mich.)  --  has said House members wouldn&apos;t vote for the Senate bill, according to the &lt;em&gt;New York Times. &lt;/em&gt;&lt;/p&gt;
&lt;p&gt;&quot;If Scott Brown wins, it&apos;ll kill the health bill,&quot; Rep. Barney Frank (D-Mass.) reportedly said last week.&lt;/p&gt;
&lt;p&gt;President Obama traveled to Massachusetts over the weekend to campaign for Coakley and today, the president sent out an e-mail pitch aimed at getting Massachusetts voters to support Coakley.&lt;/p&gt;
&lt;p&gt;&quot;Right now, the polls are open to elect a new senator to the seat that my friend Ted Kennedy held for 47 years,&quot; Obama wrote. &quot;The choice could not be more stark, and the result could not be of greater consequence  --  for Massachusetts or the nation.&quot;&lt;/p&gt;
&lt;p&gt;Polls in Massachusetts close at 8 p.m.&lt;/p&gt;


    </recommendedItem>
    <recommendedItem id="20090101_5_845"
                     title="Institutional Conflicts-of-Interest Policies Lacking in Many Medical Schools"
                     score="-0.005"
                     href="