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<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_3278"
                     title="Investigation Reveals More Woes for Rosiglitazone"
                     score="0.01"
                     href="http://www.medpagetoday.com/Cardiology/Diabetes/tb/22050?impressionId=1283742888002"
                     
      &lt;p&gt;On July 15 -- a day after the FDA completed &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/21161&quot; mce_href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/21161&quot; target=&quot;_blank&quot;&gt;two days of hearings&lt;/a&gt; on rosiglitazone (Avandia) -- a British advisory commission on drugs concluded that the product should be withdrawn from the market, according to an investigation conducted by &lt;em&gt;BMJ.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;The Commission on Human Medicines&apos; opinion was passed on to the U.K.&apos;s regulatory authority, the Medicines and Healthcare Products Regulatory Agency (MHRA), which has now told &lt;em&gt;BMJ &lt;/em&gt; that rosiglitazone &quot;no longer has a place on the U.K. market.&quot; The evidence for increased risk of cardiovascular events outweighs any potential benefit, according to an MHRA statement given to &lt;em&gt;BMJ&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Yet six weeks after the commission submitted its recommendations on rosiglitazone, the drug is still on the market in Britain. The MHRA has yet to share its negative assessment of the drug with either physicians or patients.&lt;/p&gt;
&lt;p&gt;Instead, on July 26 it sent providers a &quot;dear doctor&quot; letter suggesting merely that it would be wise to consider alternatives to rosiglitazone, wrote Deborah Cohen, features editor at &lt;em&gt;BMJ. &lt;/em&gt;&lt;/p&gt;
&lt;p&gt;The &lt;em&gt;BMJ &lt;/em&gt;investigation was detailed in a feature article published online today and also the subject of a BBC news report. The report appears to be the first confirmation that U.K. regulators are ready to withdraw the drug from the market.&lt;/p&gt;
&lt;p&gt;The lengthy article reveals no new information about the FDA&apos;s handling of rosiglitazone from its approval through two subsequent safety reviews, but it does give insight into the machinations of the approval process in Europe.&lt;/p&gt;
&lt;p&gt;For example, the European Medicines Agency initially rejected rosiglitazone, only to come back a year later in 2000 to approve the drug. As a condition of that approval, the EMA ordered a post-marketing study to verify the safety of the drug. That study, called RECORD, was an open-label trial that has been roundly criticized on both sides of the Atlantic for its poor design.&lt;/p&gt;
&lt;p&gt;Cohen quoted numerous sources who all pointed to the influence of the drug maker, GlaxoSmithKline (SmithKlineBeecham during the initial approval process), as the reason that the EMA reversed itself on rosiglitazone.&lt;/p&gt;
&lt;p&gt;&quot;According to Edwin Gale, a diabetologist and adviser to European regulators, in the years before rosiglitazone&apos;s approval diabetologists were also putting pressure on the regulators and clamouring to use this new class of drug. Some of this clamour was fuelled by pharmaceutical analysts touting its blockbuster potential, which at the time they said was crucial to Smithkline Beecham&apos;s future growth,&quot; Cohen wrote.&lt;/p&gt;
&lt;p&gt;Cohen also pointed out that the EMA does not publicly release names of members of advisory panels who review drugs for the EMA. By comparison, she wrote, the FDA process, often the subject of criticism in the U.S., is open and transparent.&lt;/p&gt;
&lt;p&gt;In a editorial that accompanied Cohen&apos;s article, Richard Lehman, PhD, of the University of Oxford, John S. Yudkin, MD, of University College in London, and Harlan Krumholz, MD, of Yale University, said there is plenty of blame to pass around in the rosiglitazone saga.&lt;/p&gt;
&lt;p&gt;Back in 1999, clinicians were &quot;strongly disposed to welcome a new drug for type 2 diabetes, and it was vigorously promoted to a receptive market,&quot; they wrote.&lt;/p&gt;
&lt;p&gt;&quot;Our mistake then -- and we have yet to put it right -- was that we did not demand better proof before we embarked on mass medication of a large group of patients who looked to us for advice and treatment.&quot;&lt;/p&gt;
&lt;p&gt;In a commentary, which was also published with the Cohen article, Nick Freemantle, PhD, of the University of Birmingham in England, argued that much of the controversy surrounding the thiazolidinediones can be laid at the feet of poor trial design -- so poor that critical questions were not answered.&lt;/p&gt;
&lt;p&gt;For example, regulators have been willing to permit high rates of loss to follow-up, especially in trials that rely on surrogate endpoints, a position that he contended &quot;makes no sense.&quot;&lt;/p&gt;
&lt;p&gt;And &quot;even when trials examine serious morbidity and mortality, loss to follow-up remains a problem. The RECORD trial, conducted to examine the safety of rosiglitazone and sponsored by GlaxoSmithKline in the UK, failed to follow-up survival in 127 participants (2.9%),&quot; he wrote. The loss to follow-up in RECORD meant that one could conclude that rosiglitazone &quot;was associated with either an increase or a decrease in mortality given different assumptions on the fate of those lost to follow-up.&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;Cohen declared no competing interests.&lt;/p&gt;&lt;p&gt;Lehman, Yudkin and Krumholz all declared they had received no support for the submitted work; no financial relationships with any organization that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work.&lt;/p&gt;&lt;p&gt;Freemantle declared no support for the submitted work, but he disclosed that he has received funding for research and travel and consulting fees from Novo Nordisk, Sanofi-Aventis, Johnson &amp;amp; Johnson, and Eli Lilly.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_3277"
                     title="Washington Week: Insurance, State Actions Top News"
                     score="0.01"
                     href="http://www.medpagetoday.com/Washington-Watch/Washington-Watch/tb/22047?impressionId=1283742888002"
                     
      &lt;p&gt;WASHINGTON -- Several studies highlighting insurance issues were released this week, including one on federal programs for kids and two others focused on employer-provided medical coverage.
&lt;p&gt;Meanwhile, a Republican governor and a Democratic senator are both trying to get their respective states exempted from following certain provisions of the healthcare reform law.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Five Million Eligible Kids Without Insurance&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;About five million children who are eligible for government health insurance programs are not enrolled in the programs, a new study published in &lt;em&gt;Health Affairs &lt;/em&gt;found.&lt;/p&gt;
&lt;p&gt;An estimated 7.3 million U.S. kids were uninsured in 2008, and 65% of them were eligible for coverage through Medicaid or the Children&apos;s Health Insurance Program (CHIP), the report found.&lt;/p&gt;
&lt;p&gt;&quot;No child should have to skip a doctor&apos;s appointment or go without the medicine they need because their family can&apos;t pay,&quot; Health and Human Services (HHS) Secretary Kathleen Sebelius said in a webcast event announcing the report&apos;s findings. &quot;Despite the great advances that states have made over the years, there are nearly five million uninsured children who are currently eligible for coverage but are not enrolled.&quot;&lt;/p&gt;
&lt;p&gt;Sebelius was joined by Secretary of Education Arne Duncan and Cindy Mann, director of the Center for Medicaid, to urge government workers, community-based organizations, health centers, and school districts to find ways to enroll the five million kids.&lt;/p&gt;
&lt;p&gt;The bulk of the children who were eligible for insurance but not enrolled lived in three states: California, Texas, and Florida, said Mann.&lt;/p&gt;
&lt;p&gt;To be eligible for CHIP or Medicaid, a child&apos;s family has to have an income below about $45,000 annually.&lt;/p&gt;
&lt;p&gt;&quot;This new data will help us to focus our efforts and our grant funding where they are most needed,&quot; Sebelius said in a statement. &quot;We now have a much better sense of where most uninsured children live, and which communities may need more help.&quot;&lt;/p&gt;
&lt;p&gt;The Children&apos;s Health Insurance Program Reauthorization Act (CHIPRA) and the healthcare reform law  --  the Affordable Care Act (ACA)  --  provide $120 million for grants to promote strategies to enroll people in government health insurance, according to HHS. Obama signed CHIPRA shortly after he took office, and signed the ACA on March 23.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Employer-Based Coverage to Grow&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Employer-sponsored insurance will not only remain a cornerstone of the American healthcare system, but it will&lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/22013&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/22013&quot; target=&quot;_blank&quot; title=&quot;Growth&amp;#8200;of&amp;#8200;Employer&amp;#8200;Plans&amp;#8200;Foreseen&amp;#8200;With&amp;#8200;Health&amp;#8200;Reform&quot;&gt; increase in prevalence&lt;/a&gt; in the post-healthcare reform environment, according to several researchers.&lt;/p&gt;
&lt;p&gt;The ACA likely will result in a large increase in employer-offered insurance, according to a Perspective article published in the Sept. 1 issue of the &lt;em&gt;New England Journal of Medicine&lt;/em&gt; (&lt;em&gt;NEJM&lt;/em&gt;).&lt;/p&gt;
&lt;p&gt;In the article, researchers from the RAND Corporation used a simulation model to predict how the healthcare market will change because of healthcare reform, and determined that the number of workers offered coverage post-reform will increase from the current 115 million workers, or 85% of the U.S. work force, to about 129 million workers, or 95% of the work force.&lt;/p&gt;
&lt;p&gt;The driving factors that will increase the prevalence of employer-sponsored insurance are the threat of being penalized and the greater availability of lower-cost plans, the researchers said.&lt;/p&gt;
&lt;p&gt;While the employer-sponsored structure is likely to remain solid, the authors of the &lt;em&gt;NEJM&lt;/em&gt; article said the nature of employer-sponsored coverage may change and more employers may opt to offer their employees plans through the exchanges.&lt;/p&gt;
&lt;p&gt;Another research group  --  the Commonwealth Fund  --  released a report Thursday that also predicts employer-based coverage will remain solid and that tax credits available to small businesses will spur increased coverage for 16.6 million small business employees.&lt;/p&gt;
&lt;p&gt;The tax credits  --  which were mandated by the ACA  --  will equal 35% of the employer&apos;s premium contribution in 2010, and increase to 50% in 2014.&lt;/p&gt;
&lt;p&gt;Over the next 10 years, small businesses and organizations could receive an estimated $40 billion in federal support through the premium credit program, the report concluded.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Worker Share of Healthcare Costs Grows&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Workers are &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/22030&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/22030&quot; target=&quot;_blank&quot; title=&quot;Employees&amp;#8200;Pay&amp;#8200;More&amp;#8200;and&amp;#8200;Get&amp;#8200;Less&amp;#8200;from&amp;#8200;Medical&amp;#8200;Coverage&quot;&gt;paying 14% more&lt;/a&gt; for their employer-sponsored plans than they did last year, as a bigger chunk of healthcare costs shifted from employers to employees, according to a new survey.&lt;/p&gt;
&lt;p&gt;Workers paid nearly $3,997 this year toward the cost of family healthcare coverage  --  up $482 from the average employee cost in 2009 and a jump of 47% from the average employee share for family coverage in 2005.&lt;/p&gt;
&lt;p&gt;Meanwhile, employers are paying an average of $9,773, down $87 from what they paid last year. Moreover, 30% of companies surveyed said they reduced the scope of benefits at the same time that they increased the amount their employees must pay for health insurance in the past year.&lt;/p&gt;
&lt;p&gt;The data come from a 2010 Employer Health Benefits Survey released Thursday by the Kaiser Family Foundation and the Health Research &amp;amp; Educational Trust.&lt;/p&gt;
&lt;p&gt;The struggling economy has caused businesses to shift more of the costs onto workers by requiring them to pay a greater share of their healthcare costs, Drew Altman, Kaiser Family Foundation president and CEO, said in a Thursday call with reporters.&lt;/p&gt;
&lt;p&gt;What employees pay for their healthcare costs has increased much more than their wages, the report found. Since 2005, workers&apos; contributions to premiums have gone up 47% while wages increased 18% (and inflation rose 12%).&lt;/p&gt;
&lt;p&gt;The ACA contains provisions that are supposed to slow the growth of healthcare spending, but it&apos;s unclear if those savings will translate into savings for the average worker.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;States Buck Healthcare Reform Law Provisions&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;A Republican governor and a Democratic senator are both attempting to &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/22026&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Reform/22026&quot; target=&quot;_blank&quot; title=&quot;States&amp;#8200;Buck&amp;#8200;Parts&amp;#8200;of&amp;#8200;Federal&amp;#8200;Reform&amp;#8200;Law&quot;&gt;exempt&lt;/a&gt; their respective states from following certain provisions of the new healthcare reform law, signaling what could emerge as a trend of states trying to distance themselves from the ACA.&lt;/p&gt;
&lt;p&gt;Minnesota governor Tim Pawlenty, a Republican, has signed an executive order directing his state&apos;s government agencies to not participate in any nonmandatory aspects of the healthcare reform law.&lt;/p&gt;
&lt;p&gt;The executive order directs all of Minnesota&apos;s executive departments and agencies not to submit applications to the federal government requesting grant funding for programs created under the ACA, unless explicitly approved by the governor&apos;s office.&lt;/p&gt;
&lt;p&gt;The order calls the ACA &quot;a dramatic attempt to assert federal command and control over this country&apos;s healthcare system&quot; and goes on to say that the act &quot;includes unprecedented federal intrusions into individual liberty, including the mandate that individual citizens are compelled to purchase health insurance under penalty of law.&quot;&lt;/p&gt;
&lt;p&gt;Meanwhile, Sen. Ron Wyden (D-Ore.) also has taken issue with the individual mandate portion of the law and wants Oregon to ignore the requirement that nearly everyone have health insurance starting in 2014.&lt;/p&gt;
&lt;p&gt;Wyden wrote a provision in the ACA that would allow states to set up their own healthcare systems as long as they meet minimum standards established by the Department of Health and Human Services. That provision doesn&apos;t go into effect until 2017, but in a letter to Oregon&apos;s Health and Human Services Department, Wyden said he&apos;d introduce legislation that would allow Oregon to set up its own system in 2014 instead.&lt;/p&gt;
&lt;p&gt;Wyden has been a longtime proponent of healthcare reform, and even had his own reform bill written years ago. His legislation, which had bipartisan support and included an individual mandate, was largely ignored during the healthcare reform debate.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Gov&apos;t to Pay for Early Retirees&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;The federal government will begin paying nearly 2,000 employers from a $5-billion fund to provide health insurance for employees who have retired early, HHS Secretary Kathleen Sebelius announced Tuesday.&lt;/p&gt;
&lt;p&gt;The ACA includes $5 billion in &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/21992&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/21992&quot; target=&quot;_blank&quot; title=&quot;&amp;#8200;HHS&amp;#8200;to&amp;#8200;Begin&amp;#8200;Paying&amp;#8200;Employers&amp;#8200;for&amp;#8200;Early&amp;#8200;Retirees&apos;&amp;#8200;Health&amp;#8200;Insurance&quot;&gt;reinsurance money&lt;/a&gt; to help employers maintain coverage for retirees ages 55 and older who are not yet eligible for Medicare. The money will pay for 80% of the cost of an enrollee&apos;s health benefits between $15,000 and $90,000.&lt;/p&gt;
&lt;p&gt;Employers must use the HHS reimbursement to reduce the employer&apos;s own healthcare costs, or to reduce the out-of-pocket costs of the employees, or a combination of both, Jay Angoff, Director of the HHS&apos; Office of Consumer Information and Insurance Oversight, said during a Tuesday afternoon webcast. The program will end in 2014 when new health insurance exchanges will begin operating and early retirees will have other coverage options.&lt;/p&gt;
&lt;p&gt;The funding is intended to incentivize employers to continue to provide insurance for early retirees, Sebelius said.&lt;/p&gt;
&lt;p&gt;&quot;We know covering early retirees has never been easy,&quot; she said. &quot;It&apos;s expensive, but it&apos;s extremely important and many employers want to continue doing the right thing. If employers are willing to cover retired workers between the ages of 55 and 65, if they&apos;re willing to make that investment, then we&apos;re going to make it happen and keep it steady until 2014.&quot;&lt;/p&gt;
&lt;p&gt;HHS will continue to accept applications for the program. It&apos;s unclear how far the $5 billion will stretch, Sebelius said.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Groups Certified to be EHR Certifiers&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;HHS has &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/21984&quot; mce_href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/21984&quot; target=&quot;_blank&quot; title=&quot;HHS&amp;#8200;Names&amp;#8200;EHR&amp;#8200;Certification&amp;#8200;Groups&quot;&gt;named&lt;/a&gt; two groups that will be in charge of certifying which electronic health record systems meet the federal government&apos;s standards for &quot;meaningful use.&quot;&lt;/p&gt;
&lt;p&gt;HHS&apos; Office of the National Coordinator for Health Information Technology (ONC) named the Chicago-based Certification Commission for Health Information Technology (CCHIT) as well as the Drummond Group in Austin, Texas, as the first two certification boards. ONC will continue to review applications for other certification bodies, according to a press release from HHS.&lt;/p&gt;
&lt;p&gt;The announcement marks a major step in the move toward widespread use of electronic health records.&lt;/p&gt;
&lt;p&gt;As part of the stimulus bill, the federal government will be offering financial incentives beginning in 2011 to physicians and hospitals that make &quot;meaningful use&quot; of electronic health records  --  $44,000 to physicians who see Medicare patients and $63,000 to physicians who see Medicaid patients.&lt;/p&gt;
&lt;p&gt;The CCHIT and the Drummond Group will be tasked with certifying which EHR products offered by vendors will allow providers to meet the meaningful use requirements. Providers who purchase the certified EHR products &quot;will have assurance that the products will support achievement of the meaningful use objectives,&quot; according to the release.&lt;/p&gt;
&lt;p&gt;&lt;strong&gt;Next Week&lt;/strong&gt;&lt;/p&gt;
&lt;p&gt;Congress continues its summer recess, returning for action on Sept. 13.&lt;/p&gt;
&lt;p&gt;Over at the FDA, the Anti-Infective Drugs Advisory Committee will meet Tuesday to discuss a new drug application for ceftaroline fosamil for injection to treat adults with community-acquired bacterial pneumonia and complicated skin and skin structure infections.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_3276"
                     title="FDA Approves New Eye Pressure Drop Formulation"
                     score="0.01"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/tb/22040?impressionId=1283742888002"
                     
      &lt;p&gt;WASHINGTON  --  The FDA approved a new formulation of the drug bimatoprost (Lumigan) in a 0.01% solution as a first-line treatment to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.&lt;/p&gt;
&lt;p&gt;Approval was based on a three-month clinical trial of patients with open-angle glaucoma or ocular hypertension, with an average baseline intraocular pressure of 23.5 mm Hg.&lt;/p&gt;
&lt;p&gt;The trial found intraocular pressure was reduced by up to 7 mm Hg with the 0.01% formulation with only one-third of the drug exposure compared with the 0.03% formulation of the same drug when the two were compared head-to-head.&lt;/p&gt;
&lt;p&gt;The drug is taken once daily as an eye drop during the evening.&lt;/p&gt;
&lt;p&gt;Bimatoprost may increase pigmentation of the iris, eyelid, and eyelashes.&lt;/p&gt;
&lt;p&gt;Patients with intraocular inflammation may exacerbate it with use of bimatoprost.&lt;/p&gt;
&lt;p&gt;The drug may cause macular edema, especially in aphakic patients, pseudophakic patients with a torn posterior lens capsule, and patients at risk for macular edema.&lt;/p&gt;
&lt;p&gt;Adverse events associated with the drug include conjuctival hyperemia, eyelash growth, and ocular pruritus.&lt;/p&gt;
&lt;p&gt;The drug is manufactured by Allergan of Irvine, Calif.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_3275"
                     title="Kids on HAART Would Benefit from Revaccinations (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/clinical-context/HIVAIDS/tb/22037?impressionId=1283742888002"
                     
      &lt;p&gt;Children with HIV who received standard childhood immunizations before starting on highly active antiretroviral therapy (HAART) could benefit from revaccination, a review published in the September issue of &lt;em&gt;Lancet Infectious Diseases&lt;/em&gt; suggests.&lt;/p&gt;
&lt;p&gt;The proportion of those with an immune response after HAART began was highly variable, with no clear trend by type of vaccine, according to a meta-analysis of 38 studies conducted by Catherine G. Sutcliffe, PhD, and William J. Moss, MD, of Johns Hopkins University.&lt;/p&gt;
&lt;p&gt;For instance, they found for tetanus the proportion with an immune response ranged from 38% to 77%. Proportions ranged from 40% to 65% for diphtheria, 1% to 100% for hepatitis B virus (HBV), and 25% to 87% by serotype for pneumococcal vaccines.&lt;/p&gt;
&lt;p&gt;The proportion of children with an immune response to the measles, mumps, rubella vaccine (MMR) after starting HAART ranged from 42% to 45% for measles virus and 27% to 66% for rubella virus.&lt;/p&gt;
&lt;p&gt;Studies looking at revaccinations after HAART was started found that within the first three months, the proportion of children with an immune response was 53% to 100% for tetanus toxoid, 75% for conjugate Hib vaccine, 46% to 92% for HBV vaccine, 29% to 96% by serotype for pneumococcal vaccine, and 50% to 100% by strain for influenza vaccine. &lt;ul&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;For the meta-analysis, Sutcliffe and Moss looked at studies addressing several different questions about HAART and vaccines. For the question of whether children taking HAART have protective immunity to vaccine-preventable diseases, studies were included if children were vaccinated before being started on HAART and measures of immunity were reported after the start of HAART but before revaccination.&lt;/p&gt;
&lt;p&gt;For questions about the short-term (three months or less) and the long-term (more than three months) immune response to vaccination while on HAART, studies were included if children were revaccinated or received new vaccines to which they had no prior exposure after being started on HAART and either short-term or long-term immune responses were measured.&lt;/p&gt;
&lt;p&gt;Two studies looked at by the authors reported antibody concentrations before and after HAART. In one of those, a Kenyan study of the measles vaccine, researchers found that the proportion of children who were seropositive increased from 33% before HAART to 42% after HAART.&lt;/p&gt;
&lt;p&gt;However, 53% of the children who were seropositive before HAART lost protective immunity, whereas 40% of children who were seronegative or had borderline antibody concentrations became seropositive after receiving HAART for six months.&lt;/p&gt;
&lt;p&gt;In terms of the strength of immunizations, in general the studies found that immunity declined but a high proportion of children maintained immunity about a year after vaccination.&lt;/p&gt;
&lt;p&gt;For tetanus toxoid, one U.S. study reported a decline from 74% seropositive at four weeks to 38% by 32 weeks after vaccination, although in three other studies 85% to 90% of children maintained immunity one year after vaccination.&lt;/p&gt;
&lt;p&gt;For pertussis, antibody concentration declined from 22.3 EU/mL at eight weeks to 10.1 EU/mL by 48 weeks and 6.8 EU/mL by 96 weeks after vaccination.&lt;/p&gt;
&lt;p&gt;For HBV, the proportion of seropositive children decreased from 46% eight weeks after revaccination to 38% after 96 weeks and 25% after a median of 4.6 years.&lt;/p&gt;
&lt;p&gt;All children remaining in the HBV study after a median of 4.6 years were revaccinated a second time. Of the children who were seronegative within one week of the second revaccination, 37% seroconverted four weeks after vaccination.&lt;/p&gt;
&lt;p&gt;The authors wrote that although HAART is effective in reducing morbidity and mortality in HIV-infected children by suppressing viral replication and restoring immune function, &quot;immune reconstitution in children is primarily through the generation of naive T cells rather than expansion of memory T cells, as in adults.&quot;&lt;/p&gt;
&lt;p&gt;Therefore, they wrote, &quot;HAART is unlikely to restore memory T cells for vaccine antigens to which children were exposed before treatment, but should restore the ability of the immune system to respond to new antigens.&quot;&lt;/p&gt;
&lt;p&gt;Because levels of immunity to vaccine-preventable diseases in HIV-infected children were generally low, the majority of children on HAART would benefit from revaccination, although the best timing of vaccination after starting HAART is still not known, either for revaccination or for primary vaccination with new vaccines, according to the researchers.&lt;/p&gt;
&lt;p&gt;&quot;Waning immunity after revaccination and vaccination with new vaccines was greater and more rapid than in children not infected with HIV, who typically maintain high antibody concentrations years after vaccination,&quot; they added.&lt;/p&gt;
&lt;p&gt;The authors cited several limitations to their meta-analysis, including the fact that few studies were identified for each vaccine and there was great heterogeneity in study design, eligibility criteria, characteristics of study populations, definitions of immunity, and presence of a comparison group. In addition, vaccine-induced immunity could not be distinguished from immunity derived from natural infection.&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 authors declared that they had no conflicts of interest. No funding information for the study was given.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_3274"
                     title="New Guidelines Out for Pneumococcal Vaccine (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/InfectiousDisease/Vaccines/tb/22034?impressionId=1283742888002"
                     
      &lt;p&gt;Adults with asthma and those who smoke should receive the 23-valent polysaccharide vaccine to prevent pneumococcal disease, according to new recommendations from the CDC.&lt;/p&gt;
&lt;p&gt;But the agency&apos;s Advisory Committee on Immunization Practices (ACIP) is no longer recommending routine use of the vaccine for all Alaska Natives and American Indians younger than 65 unless they have medical or behavioral reasons  --  such as alcohol and tobacco use  --  that put them at increased risk, or if they live in areas where the rates of invasive disease are high.&lt;/p&gt;
&lt;p&gt;The new recommendations were published in the Sept. 3 issue of &lt;em&gt;Morbidity and Mortality Weekly Report&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Herd effects have reduced the overall incidence of pneumococcal infections since the introduction of the 7-valent vaccine in 2000, but invasive disease  --  bacteremia, meningitis, or infection at other normally sterile sites  --  remains a threat, with 43,500 cases and 5,000 deaths occurring in 2009, according to the CDC.&lt;/p&gt;
&lt;p&gt;Between 1998 and 2007, the incidence of invasive disease among adults younger than 65 with high-risk conditions increased from 52% to 59%, and from 69% to 81% in those 65 and older.&lt;/p&gt;
&lt;p&gt;&quot;This trend suggests that adults with high-risk conditions might not have benefited as much from the indirect protective effects of childhood [7-valent pneumococcal conjugate vaccine] immunization as persons who are relatively healthy,&quot; the CDC report stated.&lt;/p&gt;
&lt;p&gt;As support for the asthma recommendation, CDC cited a case-control study in Tennessee that found an adjusted odds ratio of 2.4 (95% CI 1.8 to 3.3) for invasive pneumococcal disease in patients with asthma compared with those without the disease.&lt;/p&gt;
&lt;p&gt;And for smoking, CDC data from 2001 to 2003 suggested that more than half of patients ages 18 to 64 with invasive disease were current cigarette smokers.&lt;/p&gt;
&lt;p&gt;In addition, a case-control study identified a fourfold increased risk for smokers (adjusted OR 4.1, 95% CI 2.4 to 7.3), with risk correlating with number of cigarettes smoked and pack-years of smoking.&lt;/p&gt;
&lt;p&gt;Along with the vaccine, smokers should be given smoking cessation guidance, because the risk for invasive disease decreases by almost 15% each year after quitting.&lt;/p&gt;
&lt;p&gt;Estimated efficacy of the 23-valent vaccine, according to observational studies, ranges from 50% to 80% among immuncompetent adults, but efficacy is less clear, ranging from 10% to 74%, among the immunocompromised and the elderly.&lt;/p&gt;
&lt;p&gt;The report also states that everyone should receive the pneumococcal vaccine at age 65.&lt;/p&gt;
&lt;p&gt;Anyone who received a dose of the vaccine before 65 can be given a second dose if five years have passed since the first dose, and immunocompromised or asplenic patients ages 19 to 64 should be given a second dose five years after the first.&lt;/p&gt;
&lt;p&gt;Multiple revaccinations are not recommended because of uncertainty about benefits and risks.&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 authors are employees of the CDC.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
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