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<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_464"
                     title="COLUMN: &apos;Meaningful Use&apos; -- You Can Do This!"
                     score="0.01"
                     href="http://www.medpagetoday.com/Columns/18394?impressionId=1265745185617"
                     
      &lt;p&gt;Certified EHR technology used in a meaningful way is one piece of a broader Health Information Technology (HIT in techie jargon) infrastructure intended to reform the healthcare system and improve healthcare quality, efficiency, and patient safety.&lt;/p&gt;
&lt;p&gt;Under the HITECH Act, the Medicare EHR incentive programs provide payments up to $44,000 over five years to eligible professionals who are &quot;meaningful&quot; users of certified electronic health records.&lt;/p&gt;
&lt;p&gt;The Medicaid EHR program provides even bigger incentives  --  up to $63,750 over five years to practices with a 30% or higher Medicaid population for efforts to adopt, implement, or upgrade certified EHR technology or for meaningful use in the first year and up to another five years. (Pediatricians need only a 20% Medicaid patient volume to qualify.)&lt;/p&gt;
&lt;p&gt;The stimulus dollars have gotten our attention, especially in light of the eventual cuts to reimbursement scheduled to take effect in 2015 and beyond for those who don&apos;t use EHR technology.&lt;/p&gt;
&lt;p&gt;On Jan. 13, 2010 two rules were published defining the certification criteria and the criteria for meaningful use of electronic health records. (The rules are available at &lt;a href=&quot;http://www.gpoaccess.gov/fr/index.html&quot; mce_href=&quot;http://www.gpoaccess.gov/fr/index.html&quot; target=&quot;_blank&quot;&gt;www.gpoaccess.gov/fr/index.html&lt;/a&gt;.) A forthcoming rule will establish an EHR certification program. With the EHR vendors offering stimulus guarantees, the EHR certification program seems less of a concern.&lt;/p&gt;
&lt;p&gt;CMS proposed three stages of &quot;meaningful use&quot; criteria over the initial years of the program given the ongoing advancement in EHR technology and standards, as well as changes in quality measurement and other healthcare-related reporting.&lt;/p&gt;
&lt;p&gt;The focus in Meaningful Use Stage 1 is on the capture of health information in coded format and: 
&lt;ul&gt; 
&lt;li&gt;The use of it to track key clinical conditions&lt;/li&gt; 
&lt;li&gt;The communication of coded health information for care coordination purposes&lt;/li&gt; 
&lt;li&gt;Initial reporting of clinical quality measures and public health information&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The good news is that all results for all measures to be reported to CMS (for Medicare) or to the states (for Medicaid) will be done through attestation for the year 2011. In 2012, we&apos;ll be running all reports through certified EHR technology.&lt;/p&gt;
&lt;p&gt;Attestation can be achieved &quot;through a secure mechanism, such as through claims-based reporting or an online portal.&quot; But providers will still be required to &quot;use certified EHR technology to capture the data elements and calculate the results for the applicable clinical quality measures,&quot; the CMS rule said.&lt;/p&gt;
&lt;p&gt;Practices that have already implemented an EHR must ensure that their software is appropriately certified and that their clinicians are fulfilling all of the meaningful-use requirements to qualify for the incentives.&lt;/p&gt;
&lt;p&gt;So, you have just about two years to implement, iterate, rehearse, pilot, and test your own implementation against the meaningful use criteria.&lt;/p&gt;
&lt;p&gt;The initial criteria are presented in health outcomes policy priorities with associated care goals. Here are just six of the 25 criteria for Stage 1 Meaningful Use:&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Health Outcomes Policy Priority:&lt;/strong&gt;&lt;br&gt;
Improving quality, safety, efficiency, and reducing health disparities.&lt;br&gt;
&lt;strong&gt;Care Goals:&lt;/strong&gt;&lt;br&gt;
&amp;bull; Provide access to comprehensive patient health data for patient&apos;s healthcare team&lt;br&gt;
&amp;bull; Use evidence-based order sets and CPOE&lt;br&gt;
&amp;bull; Apply clinical decision support at the point of care&lt;br&gt;
&amp;bull; Generate lists of patients who need care and use them to reach out to patients&lt;br&gt;
&amp;bull; Report information for quality improvement and public reporting&lt;br&gt;

&lt;p&gt;&lt;strong&gt;Health Outcomes Policy Priority:&lt;/strong&gt;&lt;br&gt;
Engage patients and families in their healthcare.&lt;br&gt;
&lt;strong&gt;Care Goals:&lt;/strong&gt;&lt;br&gt;
Provide patients and families with timely access to data, knowledge, and tools to make informed decisions and to manage their health.&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Health Outcomes Policy Priority:&lt;/strong&gt;&lt;br&gt;
Improve care coordination.&lt;br&gt;
&lt;strong&gt;Care Goals:&lt;/strong&gt;&lt;br&gt;
Exchange meaningful clinical information among professional healthcare team.&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Health Outcomes Policy Priority:&lt;/strong&gt;&lt;br&gt;
Improve care coordination.&lt;br&gt;
&lt;strong&gt;Care Goals:&lt;/strong&gt;&lt;br&gt;
Exchange meaningful clinical information among professional healthcare team.&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Health Outcomes Policy Priority:&lt;/strong&gt;&lt;br&gt;
Improve population and public health.&lt;br&gt;
&lt;strong&gt;Care Goals:&lt;/strong&gt;&lt;br&gt;
Communicate with public health agencies.&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Health Outcomes Policy Priority:&lt;/strong&gt;&lt;br&gt;
Ensure adequate privacy and security protections for personal health information.&lt;br&gt;
&lt;strong&gt;Care Goals:&lt;/strong&gt;&lt;br&gt;
&amp;bull; Ensure privacy and security protections for confidential information through operating policies, procedures, and technologies and compliance with applicable law&lt;br&gt;
&amp;bull; Provide transparency of data sharing to patient&lt;/p&gt;

&lt;p&gt;Each of the Care Goals has defined objectives with specific measures that must be achieved to demonstrate meaningful use.&lt;/p&gt;
&lt;p&gt;Following are examples of some of the objectives and what you&apos;ll have to do to meet each.&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Objective:&lt;/strong&gt; Maintain up-to-date problem list in ICD-9-CM or SNOMED-CT.&lt;br&gt;
&lt;strong&gt;Measure:&lt;/strong&gt; 80% for unique patients.&lt;br&gt;
This objective will enable the user to manage problem lists that span multiple visits. If you&apos;ve been billing electronically, you&apos;ve already been capturing problems in ICD-9-CM format.&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Objective:&lt;/strong&gt; Generate and transmit prescriptions electronically.&lt;br&gt;
&lt;strong&gt;Measure:&lt;/strong&gt; Transmit 75% of noncontrolled drug prescriptions electronically.&lt;br&gt;
Did you hop on the e-prescribing incentives? You&apos;re ahead of this one! If not, you&apos;ll need to enable e-prescribing.&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Objective:&lt;/strong&gt; Drug screening.&lt;br&gt;
&lt;strong&gt;Measure:&lt;/strong&gt; Drug screening is enabled.&lt;br&gt;
Another easy objective to meet if you&apos;ve already implemented e-prescribing. If not, you&apos;ll need to be sure your system provides real-time alerts for drug-drug interactions and drug allergy contraindications, has an electronic formulary check, maintains drug-drug and drug-allergy warnings, and tracks the number of alerts that were responded to.&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Objective:&lt;/strong&gt; Maintain active medication list.&lt;br&gt;
&lt;strong&gt;Measure:&lt;/strong&gt; 80% for unique patients.&lt;br&gt;
You&apos;ve been doing this too with your e-prescribing implementation. The system must be able to manage an active medication list and a medication history that spans multiple visits.&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Objective:&lt;/strong&gt; Record demographics.&lt;br&gt;
&lt;strong&gt;Measure:&lt;/strong&gt; 80% for unique patients, including ALL data elements. Denominator is the number of patients seen.&lt;br&gt;
For each of your patients you should be aware of gender, race, ethnicity, date of birth, preferred language, and insurance type. You&apos;ll probably need to add fields for &quot;race&quot; and &quot;ethnicity&quot; to supplement the demographics you&apos;re already collecting.&lt;/p&gt;

&lt;p&gt;&lt;strong&gt;Objective:&lt;/strong&gt; Record vital signs.&lt;br&gt;
&lt;strong&gt;Measure:&lt;/strong&gt; 80% of patients seen age 2 and over, including ALL data elements. Denominator is total of unique patients age 2 and over seen.&lt;br&gt;
Your system must allow you to record height, weight, and blood pressure, calculate and display BMI, and plot and display growth charts for patients 2 to 20 years old, including BMI. If your system doesn&apos;t calculate BMI, ask your vendor when that will be updated in a release to your software.&lt;/p&gt;

&lt;p&gt;With the specific criteria objectives and measures such as these in hand you can implement the EHR and achieve meaningful use, improved healthcare quality and efficiency in operations.&lt;/p&gt;
&lt;p&gt;It will take work, but it can be done!&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_463"
                     title="AAPM: Online Program Helps Manage Pain (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18393?impressionId=1265745185617"
                     
      &lt;p&gt;SAN ANTONIO  --  A personalized, online self-management program helped patients with pain syndromes improve coping skills and reduce stress and depression in two studies reported here.&lt;/p&gt;
&lt;p&gt;Patients randomized to the self-management program demonstrated significant improvement in multiple social, emotional, and behavioral outcomes after six months (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01). Improvement in some parameters occurred within one month. A control group that was not exposed to the program showed no significant improvement.&lt;/p&gt;
&lt;p&gt;&quot;Our goal is to help people communicate better with providers, understand better how they can use social support, understand the comorbid conditions, like anxiety and depression, and develop cognitive skills to help get them through their pain episodes,&quot; said Emil Chiauzzi, PhD, of Inflexxion, the Newton, Mass. company that developed the program.&lt;/p&gt;
&lt;p&gt;Although the studies involved patients with migraine or low-back pain, programs are being developed for other types of pain condition, including several forms of neuropathic pain.&lt;/p&gt;
&lt;p&gt;The online program, demonstrated at &lt;a href=&quot;http://www.painACTION.com&quot; mce_href=&quot;http://www.painACTION.com&quot; target=&quot;_blank&quot;&gt;www.painACTION.com&lt;/a&gt;, employs patient-specific information to generate individualized self-management strategies.&lt;/p&gt;
&lt;p&gt;Patient responses to assessments are analyzed by a &quot;recommendation engine,&quot; which produces content recommendations designed to address each patient&apos;s informational and self-management needs.&lt;/p&gt;
&lt;p&gt;Elements on the Web site include multimedia education units, a pain inventory, interactive tools that provide information based on patient-provider communication, and medication risk management.&lt;/p&gt;
&lt;p&gt;&quot;The content on the Web site is focused on teaching people practical skills to manage the behavioral side of pain,&quot; Jonas Bromberg, PsyD, also of Inflexxion, said in an interview.&lt;/p&gt;
&lt;p&gt;Bromberg presented results of a randomized study involving 210 patients, all of whom met International Headache Society diagnostic criteria for migraine, with or without aura.&lt;/p&gt;
&lt;p&gt;Patients assigned to the online program completed at least eight 30-minute session during the first month of the study and at least five more 30-minute sessions during the five-month follow-up period. Patients in the control group continued to receive usual care without exposure to the Web site.&lt;/p&gt;
&lt;p&gt;Participants assigned to the online program had a minimum set of requirements for each session, which were provided at log-in. Follow-up assessments occurred at one, three, and six months.&lt;/p&gt;
&lt;p&gt;The two groups were balanced with respect to sex and headache frequency and severity, the researchers said.&lt;/p&gt;
&lt;p&gt;Bromberg reported that patients assigned to the self-management program demonstrated significant improvement in: &lt;ul&gt; &lt;li&gt;Headache self-efficacy (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01 compared with baseline)&lt;/li&gt; &lt;li&gt;Use of relaxation (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Use of social support (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Pain catastrophizing (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Depression (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05 to &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Stress (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Chiauzzi presented results from a randomized study of 209 patients with low-back pain. The design was similar to that of the migraine study, except results were analyzed for between-group differences.&lt;/p&gt;
&lt;p&gt;The results showed significant improvement in the study group versus control group with respect to: &lt;ul&gt; &lt;li&gt;Stress (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Coping (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Social supports (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The data showed significant effects of both treatment (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01) and time (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01) favoring the Web site versus control. Chiauzzi said patients assigned to the Web site had greater mean improvement at posttest, three months, and six months.&lt;/p&gt;
&lt;p&gt;Qualitative analysis suggested that Web site participants had clinically meaningful improvement in depression, anxiety, and stress.&lt;/p&gt;
&lt;p&gt;Additionally, patients in the self-management program reported a 12.3% decrease in pain from baseline, versus 7% in the control group.&lt;/p&gt;
&lt;p&gt;Access to the Web site did not improve physical functioning.&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 studies were funded by the National Institutes of Health.&lt;/p&gt;&lt;p&gt;Chiauzzi and Bromberg are employees of Inflexxion, developer of the online program.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_462"
                     title="BLOG: Good Conscience is Bad Business"
                     score="0.01"
                     href="http://www.medpagetoday.com/Blogs/18386?impressionId=1265745185617"
                     
      &lt;span style=&quot;font-family: Times; font-size: medium;&quot;&gt;&lt;div style=&quot;margin: 0px; padding: 0.6em; background-color: rgb(255, 255, 255); font-family: Georgia,&apos;Times New Roman&apos;,&apos;Bitstream Charter&apos;,Times,serif; font-style: normal; font-variant: normal; font-weight: normal; font-size: 13px; line-height: 19px; font-size-adjust: none; font-stretch: normal; -x-system-font: none;&quot;&gt;&lt;p&gt;I am going to state something that is completely obvious to most primary care physicians:  &lt;span style=&quot;font-style: italic;&quot; mce_style=&quot;font-style: italic;&quot; mce_name=&quot;em&quot;&gt;I do not accept Medicare and Medicaid patients because it is good business, I accept them despite the fact that it is bad business.&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;In truth, I could make that statement about insurance as a whole; my life would be easier and my income would be less precarious if I did not accept any insurance.  If I did, I would charge a standard amount per visit based on time spent and require payment at the time of that visit.  This is totally obvious to me, and I suspect to most primary care physicians.  A huge part of our overhead comes from the fact that we are dealing with insurance.  A huge part of our headache and hassle comes from the fact that we are dealing with insurance.&lt;/p&gt;
&lt;p&gt;If I chose to post my charges up front and expected payment at the time of the visit, the impact to the business would be huge. As  it stands, the percentage of my collections that goes to overhead is between 50 and 60% (depending on the month).  A huge amount of that overhead is due to the need to hire a large billing staff to deal with the complexity of coding, billing, and documenting.  If I dropped insurance and charged a fixed amount, I could:&lt;/p&gt;
&lt;ol&gt;
&lt;li&gt;Cut my billing staff nearly to zero (someone would still have to do bookkeeping).&lt;/li&gt;
&lt;li&gt;Increase my payment per visit, which would allow me to see fewer patients per day.&lt;/li&gt;
&lt;li&gt;Document for the sake of patient care, and not for the sake of getting paid.&lt;/li&gt;
&lt;li&gt;Add extra services like email access and house calls without worrying about how I would get paid.&lt;/li&gt;
&lt;/ol&gt;
&lt;p&gt;In short, I could make my life better, my hassles less, and improve the quality of the care I offer.&lt;/p&gt;
&lt;p&gt;So why just single out Medicare and Medicaid?  Dropping insurance would force all of my M/M patients to find another doctor, while my patients with insurance could still choose to see me.  There are several reasons why this is possible for insured patients:&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;Insured patients generally have the option of filing for their own insurance (there are some that still don&apos;t allow this, but that number is dwindling with the decrease of HMO&apos;s).&lt;/li&gt;
&lt;li&gt;Insured patients could choose to just pay me cash if they choose.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;Can&apos;t Medicare/Medicaid patients do this?  No, for several reasons:&lt;/p&gt;
&lt;ul&gt;
&lt;li&gt;If a doctor does not accept M/M, the government will not pay anything for the visit regardless of who files.&lt;/li&gt;
&lt;li&gt;If the doctor &lt;span style=&quot;font-style: italic;&quot; mce_style=&quot;font-style: italic;&quot; mce_name=&quot;em&quot;&gt;does&lt;/span&gt; accept M/M, they are required to accept that payment and cannot charge anything outside of that (aside from the 20% not covered).  So if I charge a M/M patient $50 cash for a visit and am signed up to accept M/M, I am committing fraud.&lt;/li&gt;
&lt;li&gt;If I drop M/M, I cannot sign up for it again for 3 years, so the impact of that move is too large to consider at this time.&lt;/li&gt;
&lt;/ul&gt;
&lt;p&gt;So why in the world do I accept M/M still?  Why would I continue to make my life so difficult?  Two words: duty and calling. I view my seeing M/M patients as a social responsibility (especially Medicare).  These people need to be seen and they deserve good care, and despite the hassle and drain on income they cause, I make a reasonable income.  So far.&lt;/p&gt;
&lt;p&gt;Plus, I just like to take care of the elderly and the poor.  My personal reasons for going into medicine included both a desire to have a good job and the calling to care for people in need.  If I dropped M/M I would reject the calling for personal gain, which is something I can&apos;t do in good conscience at this time.&lt;/p&gt;
&lt;p&gt;The fact that the only thing keeping me accepting M/M is my conscience (and tolerance of pain) gives a really clear explanation as to why M/M are failing in the realm of primary care.  The government is not paying enough to make a good business case to accept M/M; instead it is relying on the consciences of primary care physicians like me who are willing to put up with the &lt;span style=&quot;font-style: italic;&quot; mce_style=&quot;font-style: italic;&quot; mce_name=&quot;em&quot;&gt;huge&lt;/span&gt; hassle of the system.  I am personally willing to continue on this course as long as (it doesn&apos;t get too much worse) but I have complete sympathy for PCP&apos;s who drop insurance and no longer see M/M patients.&lt;/p&gt;
&lt;p&gt;One of the biggest costs to our system is the high proportion of specialists to PCP&apos;s.  PCP&apos;s keep down cost, as their success is measured by keeping people healthy, away from specialists, and out of the hospital.  The system is just holding on with the PCP&apos;s we have; decreasing that number would be devastating and perhaps fatal to the system.  It&apos;s a very bad sign when the best business model for PCP&apos;s is to do something that, if done by all PCP&apos;s, would wreck the system.  Yet even physicians like myself, who have a strong sense of duty and social responsibility, wonder how long we can afford to take M/M.&lt;/p&gt;
&lt;p&gt;I am sure some are thinking: &lt;span style=&quot;font-style: italic;&quot; mce_style=&quot;font-style: italic;&quot; mce_name=&quot;em&quot;&gt;Poor Doctors!  They have to earn less money!  They have to actually have a conscience!  What a horrible thing! &lt;/span&gt;To that I answer with the fact that I &lt;span style=&quot;font-style: italic;&quot; mce_style=&quot;font-style: italic;&quot; mce_name=&quot;em&quot;&gt;have&lt;/span&gt; chosen to earn less money, increase my hassle, and live by my conscience.  At this time, most PCP&apos;s accepting M/M are doing the same.  But setting up a system that requires the choice between conscience and sanity, between doing the right thing and self-care, is foolish.  Pushing down M/M payments for PCP&apos;s will make a bad situation worse.&lt;/p&gt;
&lt;p&gt;That&apos;s bad politics, bad medicine, and bad business.&lt;/p&gt;
&lt;p&gt;Consider yourself warned, Washington.&lt;/p&gt;
&lt;/div&gt;
&lt;/span&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_461"
                     title="Limited Benefit Seen in CML Drug, FDA Says"
                     score="0.01"
                     href="http://www.medpagetoday.com/HematologyOncology/Leukemia/tb/18390?impressionId=1265745185617"
                     
      &lt;p&gt;WASHINGTON  --  Chronic myeloid leukemia (CML) patients who are resistant to imatinib (Gleevec) had a low response rate to treatment with omacetaxine (Omapro), according to Food and Drug Administration (FDA) reviewers.&lt;/p&gt;

&lt;p&gt;The FDA released its assessment of omacetaxine, made by ChemGenex Pharmaceuticals, in preparation for a meeting of an outside panel of oncology experts who will recommend whether the agency should approve the drug for imanitib-resistant CML patients with a Bcr-Abl T3151 mutation.&lt;/p&gt;
    &lt;p&gt;That meeting, original scheduled for Wednesday, was postponed when the federal government closed most Washington area offices because of snow. An FDA spokesman said no new date has been set.&lt;/p&gt;


&lt;p&gt;The agency does not have to follow the advice of its advisory panels, but it usually does.&lt;/p&gt;
&lt;p&gt;The Oncologic Drugs Advisory Committee will look at data from manufacturer ChemGenex&apos;s lone trial, which tested the safety and efficacy of subcutaneously administered omacetaxine in the target population.&lt;/p&gt;
&lt;p&gt;The trial divided 66 patients into disease stage cohorts of &quot;chronic phase,&quot; &quot;accelerated phase,&quot; or &quot;blast phase,&quot; and gave them 1.25 mg/m&lt;sup&gt;2&lt;/sup&gt; subcutaneous omacetaxine twice daily for 14 days every 28 days until hematologic response for induction therapy.&lt;/p&gt;
&lt;p&gt;If a patient achieved a complete hematologic response, hematologic improvement, or any cytogenetic response, the patient was transitioned to a maintenance does twice daily for seven days every 28 days.&lt;/p&gt;
&lt;p&gt;Researchers found: &lt;ul&gt; &lt;li&gt;For the chronic phase cohort of 40 patients, the major cytogenetic response rate was 15%, and the median duration of response was 7.7 months. &lt;/li&gt; &lt;li&gt;After a mean of nine months, 86% of the 49 chronic patients who were no longer controlling their diseases with imatinib had achieved a complete hematological response. &lt;/li&gt; &lt;li&gt;For the &quot;accelerated phase&quot; cohort of 16 patients, the major cytogenetic response rate was 6%, and the complete hematological response rate was 31%, with a median of duration of response of 22 weeks. &lt;/li&gt; &lt;li&gt;No patients responded in the more severe &quot;blast&quot; group, indicating omacetaxine works best among patients who are not as sick.&lt;/li&gt; &lt;li&gt;Overall, about 27% of patients achieved a major cytogenetic response, defined as absence of Bcr-Abl mutation in at least 35% of cells. About 18% of the patients had achieved a complete cytogenetic response, defined as all cells appearing to have lost the Bcr-Abl mutation.&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;&quot;The response rate observed in the efficacy study was low,&quot; FDA reviewers concluded in documents released in advance of Wednesday&apos;s meeting.&lt;/p&gt;
&lt;p&gt;However, ChemGenex researchers said, &quot;These results demonstrate that omacetaxine is an effective and durable therapy with rapid onset of action for CML patients with the Bcr-Abl T315I mutation.&quot;&lt;/p&gt;
&lt;p&gt;The most common adverse events in the trial were thrombocytopenia, anemia, diarrhea, and neutropenia.&lt;/p&gt;
&lt;p&gt;The FDA reviewers cited a number of concerns with the ChemGenex study, noting that the company planned to enroll 100 patients but submitted efficacy data from only 66, and then continued to enroll additional patients after the prespecified data cutoff.&lt;/p&gt;
&lt;p&gt;Also, the reviewers said there is no commercially available test to detect the T3151 mutation. And, although it was a requirement of the study that the patients have a confirmed T3151 mutation, the mutation status of 35% of the patients in the trial was not confirmed.&lt;/p&gt;
&lt;p&gt;There are currently no approved drugs that have been found to be effective at treating CML patients with the T315I mutation.&lt;/p&gt;
&lt;p&gt;&quot;Omacetaxine offers an important therapeutic option for the treatment of CML patients who have the T315I mutation, a population that has a clear unmet medical need and no proven treatment options,&quot; ChemGenex researchers wrote in the company&apos;s briefing document.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_460"
                     title="Black Mothers at Increased Risk for Cardiomyopathy (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/Cardiology/Prevention/tb/18389?impressionId=1265745185617"
                     
      &lt;p&gt;African-American women have an increased risk of peripartum cardiomyopathy, researchers have found in a small, single-center Georgia study.&lt;/p&gt;
&lt;p&gt;Compared with healthy controls of other races, black women had a 15.7-fold increased risk of the dangerous heart condition (95% CI 3.5 to 70.6, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001), Mindy B. Gentry, MD, of the Medical College of Georgia Cardiovascular Center in Augusta, and colleagues reported online in the &lt;em&gt;Journal of the American College of Cardiology&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;The researchers said that the findings &quot;could not be explained by several other factors,&quot; including hypertension and smoking.&lt;/p&gt;
&lt;p&gt;&quot;We are unable to determine in this study whether genetic factors of race, or other complex environmental, social, economic, or other factors that are linked to race, account for the increased risk,&quot; the researchers wrote.&lt;/p&gt;
&lt;p&gt;Peripartum cardiomyopathy is a major cause of heart failure and cardiovascular mortality among women of child-bearing age, and can occur in women without preexisting heart disease.&lt;/p&gt;
&lt;p&gt;However, its risk factors have not yet been established, the researchers said.&lt;/p&gt;
&lt;p&gt;So they conducted a single-center, case-control study involving 28 women diagnosed with peripartum cardiomyopathy. Each case was matched with three healthy controls: all delivered babies within the same month.&lt;/p&gt;
&lt;p&gt;The researchers found that case incidence was 24 in 100,000 deliveries for non-blacks and 340 in 100,000 for African Americans.&lt;/p&gt;
&lt;p&gt;That relationship remained significant in multivariate analyses, controlling for other factors (OR 31.5, 95% CI 3.6 to 277.6).&lt;/p&gt;
&lt;p&gt;Other significant risk factors included hypertension (OR 10.8, 95% CI 2.6 to 44.4), being unmarried (OR 4.2, 95% CI 1.4 to 12.3), and having had more than two previous pregnancies (OR 2.9, 95% CI 1.1 to 7.4).&lt;/p&gt;
&lt;p&gt;It wasn&apos;t significant in the univariate analysis, but smoking during pregnancy was a significant risk factor in the multivariate analysis, the researchers said.&lt;/p&gt;
&lt;p&gt;Yet in a stratified analysis, &quot;none of these risk factors could explain solely the increased risk for this disorder among African-American women,&quot; they wrote.&lt;/p&gt;
&lt;p&gt;They noted that the frequency of cardiomyopathy was higher at their center than in previous reports, although it was comparable to the frequency in countries with more women of African descent (100 to 980 in 100,000 deliveries).&lt;/p&gt;
&lt;p&gt;&quot;These data and an analysis of previous reports provide strong, consistent evidence that the risk of peripartum cardiomyopathy is increased among women of African descent,&quot; they concluded. &quot;It is important to consider whether the increased risk is due to genetic factors, environmental factors, or both.&quot;&lt;/p&gt;
&lt;p&gt;The authors noted that the study was limited by a relatively small sample size.&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 researchers reported no conflicts of interest.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
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