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    <recommendedItem id="20100101_19_368"
                     title="Lancet Retracts 1998 MMR-Autism Paper"
                     score="0.01"
                     href="http://www.medpagetoday.com/Pediatrics/Vaccines/tb/18255?impressionId=1265778579340"
                     
      &lt;p&gt;Editors of &lt;em&gt;The Lancet&lt;/em&gt; have retracted the 1998 study that first suggested autism might be caused by the MMR vaccine, less than a week after an official rebuke to the paper&apos;s lead author, Andrew Wakefield, MBBS, and two co-authors.&lt;/p&gt;
&lt;p&gt;In a brief note posted on the journal&apos;s Web site, &lt;em&gt;Lancet&lt;/em&gt; editors wrote, &quot;It has become clear that several elements of the 1998 paper by Wakefield et al. are incorrect, contrary to the findings of an earlier investigation.... Therefore, we fully retract this paper from the published record.&quot;&lt;/p&gt;
&lt;p&gt;Evidence presented in a Jan. 28 hearing before the U.K. General Medical Council&apos;s Fitness to Practise Panel persuaded the journal that the paper had misrepresented how the study was conducted.&lt;/p&gt;
&lt;p&gt;&lt;span class=&quot;msgBody&quot;&gt;The council, which has no direct American equivalent, is an independent, nationwide regulatory body that registers doctors and enforces standards of medical practice in the U.K.&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;Hospital records and other sources contradicted findings of a 2004 investigation by Wakefield&apos;s institution, the Royal Free and University College, that the study had been properly vetted by an institutional review board.&lt;/p&gt;
&lt;p&gt;&quot;The claims in the original paper that children were &apos;consecutively referred&apos; and that investigations were &apos;approved&apos; by the local ethics committee have been proven to be false,&quot; according to the &lt;em&gt;Lancet&lt;/em&gt; editors.&lt;/p&gt;
&lt;p&gt;The editor of Britain&apos;s other leading medical journal, &lt;em&gt;BMJ&lt;/em&gt;, congratulated &lt;em&gt;The Lancet&lt;/em&gt; for its action.&lt;/p&gt;
&lt;p&gt;&quot;This will help to restore faith in this globally important vaccine and in the integrity of the scientific literature,&quot; according to a statement from Fiona Godlee, MB, BChir, BSc.&lt;/p&gt;
&lt;p&gt;In the 1998 paper, Wakefield and colleagues reported on findings in 12 children who, they said, had developed intestinal inflammation and autistic symptoms following MMR vaccination. They suggested that the inflammation released gut proteins into the circulation that eventually migrated to the brain, causing permanent damage reflected in autism symptoms.&lt;/p&gt;
&lt;p&gt;The report and the ensuing mass-media publicity sparked consternation among parents and the medical community. Vaccination rates in Britain and the U.S. dropped sharply, and measles rates spiked in consequence.&lt;/p&gt;
&lt;p&gt;Although subsequent population-based research and other studies have failed to confirm a causal link between MMR vaccines and autism, a vocal group of parents of autistic children continues to insist that it is real. They call Wakefield a hero.&lt;/p&gt;
&lt;p&gt;However, a nearly decade-long investigation by a British journalist, Brian Deer, uncovered discrepancies between the &lt;em&gt;Lancet&lt;/em&gt; paper and hospital records and other sources. (See &lt;a href=&quot;http://www.medpagetoday.com/Pediatrics/Autism/12850&quot; mce_href=&quot;http://www.medpagetoday.com/Pediatrics/Autism/12850&quot; target=&quot;_blank&quot;&gt;Father of Vaccine-Autism Link Said to Have Fudged Data&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;Whereas the &lt;em&gt;Lancet&lt;/em&gt; paper indicated that, in most cases, symptoms developed within days of vaccination, the records indicated that this was true only for one child, according to Deer&apos;s account in the &lt;em&gt;Times of London&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;The patients&apos; records also indicated that five of the children had psychosocial problems before vaccination, said the &lt;em&gt;Times&lt;/em&gt;, but the &lt;em&gt;Lancet&lt;/em&gt; paper described them as &quot;developmentally normal.&quot;&lt;/p&gt;
&lt;p&gt;In addition, the &lt;em&gt;Lancet&lt;/em&gt; paper described abnormal intestinal pathology results in the children, but the hospital pathology reports showed no findings of inflammation, the &lt;em&gt;Times&lt;/em&gt; report said.&lt;/p&gt;
&lt;p&gt;At last week&apos;s hearing, the U.K.&apos;s General Medical Council panel heard evidence that Wakefield had taken blood samples from children attending his son&apos;s birthday party and performed spinal taps on other children in a hospital without due regard for their safety.&lt;/p&gt;
&lt;p&gt;The panel found Wakefield guilty of more than 30 charges that he had acted unethically in conducting the study. He could be stripped of his license to practice in Britain, but no ruling has been made yet.&lt;/p&gt;
&lt;p&gt;Two of Wakefield&apos;s 12 co-authors on the 1998 paper, John Walker-Smith, MD, and Simon Murch, PhD, were also found to have committed ethical violations. The other 10 co-authors had previously repudiated the paper&apos;s findings and were not charged.&lt;/p&gt;
&lt;p&gt;Wakefield was in London while the hearing took place but did not attend. Afterward, he told reporters he was innocent of wrongdoing and would continue his research.&lt;/p&gt;
&lt;p&gt;Wakefield is now based at Thoughtful House, a private autism research and treatment facility in Austin, Texas. After the panel&apos;s ruling, it issued a statement expressing disappointment and calling the charges &quot;unfounded and unfair.&quot;&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_343"
                     title="U.S. Marshals Seize Unapproved Ozone Generators"
                     score="0.008"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/EnvironmentalHealth/tb/18228?impressionId=1265778579340"
                     
      &lt;p&gt;WASHINGTON  --  U.S. Marshals have seized 77 unapproved ozone generators, valued at almost $76,000 from a California device manufacturer, the FDA announced.&lt;/p&gt;
&lt;p&gt;The devices were advertised as treatments for various conditions, including cancer, AIDS, hepatitis, herpes, and other diseases, but lacked approval or efficacy data to support the claims made on their behalf, an FDA release said.&lt;/p&gt;
&lt;p&gt;The raid came after the company, Applied Ozone Systems (AOS) of Auburn, Calif., failed to respond to a voluntary recall request last December, the agency said.&lt;/p&gt;
&lt;p&gt;The FDA raised concerns that patients using AOS-IM and AOS-IMD devices will consider it an appropriate treatment for an affliction and delay or stop FDA-approved and proven medical treatments. Patients using the devices may risk infection from contamination of the applicator or catheter, the release said.&lt;/p&gt;
&lt;p&gt;The FDA recommended that healthcare professionals and consumers cease use of the devices.&lt;/p&gt;
&lt;p&gt;The agency said it obtained an inspection warrant for the company&apos;s manufacturing facilities after the owner refused to admit FDA inspectors. It said the inspection revealed several breaches of the FDA&apos;s good manufacturing practice requirements for medical devices, which had never been approved in the first place.&lt;/p&gt;
&lt;p&gt;Ozone is an unstable allotrope of oxygen with three atoms, instead of the normal two. Ozone generators produce ozone from oxygen and have consumer and industrial applications, but ozone itself is harmful to the respiratory system, even at relatively low concentrations.&lt;/p&gt;
&lt;p&gt;Instructions with the Applied Ozone Systems devices suggest blowing ozoned air into the rectal and vaginal areas.&lt;/p&gt;
&lt;p&gt;Friday&apos;s seizure was part of a joint effort of the FDA and the California Department of Public Health to remove or prevent unapproved or unsafe medical devices from entering the market.&lt;/p&gt;
&lt;p&gt;A statement on the company&apos;s Web site said the two ozone generator models, which sold for $750 and $1,200 respectively, were no longer available by order of the FDA and California authorities.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20090101_9_459"
                     title="Autism Diagnoses Buried on Pediatricians&apos; Back Burners"
                     score="-0.005"
                     href="