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    <recommendedItem id="20100101_19_414"
                     title="H1N1 Vaccination Still a Good Idea, CDC Says"
                     score="0.011"
                     href="http://www.medpagetoday.com/InfectiousDisease/SwineFlu/tb/18325?impressionId=1265793570958"
                     
      &lt;p&gt;Although pandemic H1N1 influenza activity appears to have leveled off, the CDC remains wary of what the future may hold.&lt;/p&gt;
&lt;p&gt;No states were reporting widespread influenza activity, and only six  --  Alabama, Georgia, Maine, New Jersey, New Mexico, and Virginia  --  were reporting regional activity, Anne Schuchat, MD, director of the CDC&apos;s National Center for Immunization and Respiratory Diseases, told reporters on a conference call today.&lt;/p&gt;
&lt;p&gt;Influenza-like activity remained below the baseline level for this time of year for the third straight week, Schuchat said.&lt;/p&gt;
&lt;p&gt;&quot;That&apos;s fairly similar to what we would normally see at this time of year with seasonal flu,&quot; she said.&lt;/p&gt;
&lt;p&gt;However, she said that the H1N1 virus continues to circulate, causing severe disease and death in some cases.&lt;/p&gt;
&lt;p&gt;Although total activity is down, Schuchat noted that the proportion of deaths attributed to either flu or pneumonia is higher than the epidemic threshold, and has been for the past three weeks. The reasons were unclear, but she said there are no indications that the virus has become more virulent.&lt;/p&gt;
&lt;p&gt;But, she said, &quot;H1N1 vaccination remains a good idea.&quot;&lt;/p&gt;
&lt;p&gt;The most recent results of the CDC&apos;s National H1N1 Flu Survey revealed that about 70 million people, or 23.4% of Americans, have been vaccinated so far. About 76 million doses of the vaccine have been used because of the requirement that children younger than 10 get two.&lt;/p&gt;
&lt;p&gt;About 37% of children up to age 18 have been vaccinated. For those younger than 10, 37% have received their second dose.&lt;/p&gt;
&lt;p&gt;Vaccine supply remains ample, Schuchat said, with about 124 million doses shipped around the country up to this point.&lt;/p&gt;
&lt;p&gt;Citing an &quot;unprecedented&quot; effort to monitor safety, she said there have not been any major safety concerns identified.&lt;/p&gt;
&lt;p&gt;&quot;So if safety was the reason that you were waiting, I think you can be reassured on that front.&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=1265793570958"
                     
      &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_19_2059"
                     title="ACIP: Zanamivir Best for All Flu, Including New H1N1"
                     score="-0.005"
                     href="http://www.medpagetoday.com/MeetingCoverage/ACIP/tb/14896?impressionId=1265793570958"
                     
      ATLANTA, June 29 -- Zanamivir (Relenza), a neuraminidase inhibitor, should be the preferred treatment for patients with influenza-like illness, whether infection is caused by a seasonal virus or the pandemic H1N1 virus, an advisory committee to the CDC said.
              &lt;p&gt; 
              &lt;p&gt;Even if laboratory tests are negative but flu is still suspected, zanamivir should be used when antiviral treatment is considered, the Advisory Committee on Immunization Practices agreed here.
              &lt;p&gt; 
              &lt;p&gt;Oseltamivir (Tamiflu), another neuraminidase inhibitor, could be used in case of a test that&apos;s positive for seasonal influenza A H3N2 or B, or for pandemic influenza A H1N1, although more than 99% of the seasonal H1N1 viruses were resistant to the drug, the committee noted.
              &lt;p&gt; 
              &lt;p&gt;The recommendations were based on testing for antiviral resistance, which found that all strains recently isolated, including the new H1N1, were susceptible to zanamivir.
              &lt;p&gt; 
              &lt;p&gt;Researchers found varying levels of resistance to the adamantanes, rimantadine and amantadine.
              &lt;p&gt; 
              &lt;p&gt;The recommendations, which will be published in an upcoming issue of &lt;em&gt;Morbidity and Mortality Weekly Report&lt;/em&gt;, stressed that treatment should start as soon as possible for patients needing treatment.
              &lt;p&gt; 
              &lt;p&gt;The advisory panel said antiviral treatment should be considered for patients hospitalized with flu, those with influenza viral pneumonia, those with flu and complicating bacterial pneumonia, and those with flu who are at higher risk for flu-related complications, such as pregnant women and those with comorbidities, regardless of illness severity.
              &lt;p&gt; 
              &lt;p&gt;Anthony Fiore, MD, MPH, of the influenza division of CDC&apos;s National Center for Immunization and Respiratory Diseases, said the recommendations may change depending on how the upcoming flu season develops.
              &lt;p&gt; 
              &lt;p&gt;&quot;It&apos;s very important for clinicians to keep abreast of what the current recommendations are, because there&apos;s a potential for them changing according to epidemiology or to antiviral supply or susceptibility issues,&quot; said Dr. Fiore, who took part in crafting the recommendations.
              &lt;p&gt; 
              &lt;p&gt;Zanamivir is taken by inhalation and is not recommended for those with asthma or other respiratory diseases. It is also not approved for treating influenza in children under 7.
              &lt;p&gt; 
              &lt;p&gt;ACIP also tackled guidance on antiviral chemoprophylaxis, but agreement proved more problematic.
              &lt;p&gt; 
              &lt;p&gt;Some committee members questioned the notion of including detailed guidance in a document issued once a year, because it would become outdated relatively quickly.
              &lt;p&gt; 
              &lt;p&gt;&quot;In the face of the novel H1N1, the chemoprophylaxis recommendations strike me as impractical or obsolete,&quot; said Paul Cieslak, MD, of the Oregon Public Health Division in Portland, and an ACIP member. &quot;They would have us prophylaxing a huge percentage of the American public indefinitely into the future.&quot;
              &lt;p&gt; 
              &lt;p&gt;He said Oregon would not follow the guidelines as written and that more vague wording would be preferable to the proposed guidance.
              &lt;p&gt; 
              &lt;p&gt;But fellow ACIP member Carol Baker, MD, of Baylor College of Medicine in Houston, disagreed.
              &lt;p&gt; 
              &lt;p&gt;&quot;I do think because of all the media attention we do need to have some recommendations, with a strong caveat that these will probably be changing,&quot; she said. &quot;But I think we need to continue to give some guidance right now or we&apos;re not doing our job.&quot;
              &lt;p&gt; 
              &lt;p&gt;Ultimately, the committee included a short section referring clinicians to a Web site that would be updated as needed by the CDC.
              &lt;p&gt; 
              &lt;p&gt;The section would include a list of patients who might be considered for prophylaxis, such as young children or those with congestive heart failure and diabetes, along with instructions to check the Web site for the latest specific recommendations, according to Dr. Fiore.
            
    </recommendedItem>
    <recommendedItem id="20090101_19_1294"
                     title="IVW: Pandemic Vaccines May be Too Little, Too Late"
                     score="-0.006"
                     href="http://www.medpagetoday.com/InfectiousDisease/SwineFlu/tb/13943?impressionId=1265793570958"
                     
      CANNES, France, April 28 -- If the swine flu outbreak develops into a pandemic -- and that&apos;s a big if -- the earliest the public would see a vaccine against the disease would be September, a researcher said here at the conference on Influenza Vaccines for the World.
              &lt;br&gt; 
              &lt;br&gt;And that&apos;s if the government asks industry to start production today, said Klaus Stohr, D.V.M., vice president and global head of Novartis Vaccines and Diagnostics and former head of the World Health Organization&apos;s global influenza program.
              &lt;br&gt; 
              &lt;br&gt;&quot;What we have seen the last two or three days is that the current pandemic vaccine system is not ideal not only in terms of timing . . . but also in terms of vaccine production,&quot; he said.
              &lt;br&gt; 
              &lt;br&gt;Any hopes that the version of H1N1 in the current seasonal vaccine would provide protection against the swine flu seemed to be dashed by preliminary data from Novartis-run tests.
              &lt;p&gt; 
              &lt;p&gt;Dr. Stohr said the findings suggested the H1N1 viruses contained in seasonal vaccines all the way back to 1980 are more closely related to each other than any are to the new virus, although he cautioned that more study was needed before concluding that there wouldn&apos;t be cross-protection.
              &lt;p&gt; 
              &lt;p&gt;He said that the outbreak of swine influenza A H1N1 has not changed &quot;the assessment that pandemic vaccines are too little, too late, and that they are not going to be a solution even for countries that have domestic vaccine production.&quot;
              &lt;p&gt; 
              &lt;p&gt;Based on the current state of the swine flu investigation -- ongoing clinical, epidemiological, and virological studies -- it would take about two weeks for vaccine strain preparation, he said.
              &lt;p&gt; 
              &lt;p&gt;Seed virus preparation would take another three or four weeks, putting the start of bulk production at the end of June, Dr. Stohr said.
              &lt;p&gt; 
              &lt;p&gt;Standardizing reagents would not be available for another eight weeks, and quality control would tack on an additional one to two, he said.
              &lt;p&gt; 
              &lt;p&gt;Only then, in early September, would Novartis and other vaccine makers start distributing vaccine, he said.
              &lt;p&gt; 
              &lt;p&gt; 
              &lt;p&gt;Any decisions regarding pandemic vaccine production, he said, are complicated by the fact that nobody knows whether the virus will cause a pandemic, become endemic in humans causing continuous small outbreaks, or fizzle out and disappear.
              &lt;p&gt; 
              &lt;p&gt;If the virus were to &quot;disappear&quot; though, that would not necessarily eliminate the need to prepare for its re-emergence if it remained in an animal reservoir, Dr. Stohr said.
              &lt;p&gt; 
              &lt;p&gt;A possible solution would be development of a tetravalent seasonal flu vaccine, he said.
              &lt;p&gt; 
              &lt;p&gt;Further complicating decision-making is the looming threat of an H5N1 avian flu pandemic.
              &lt;p&gt; 
              &lt;p&gt;&quot;The absolute risk of H5N1 to cause a pandemic has not changed,&quot; he said. &quot;It remains a strain with high pandemic potential.&quot;
              &lt;p&gt; 
              &lt;p&gt;Swine flu, however, has bumped it down to number two on the list, he said.
              &lt;p&gt; 
              &lt;p&gt;The swine flu outbreak serves as &quot;a stark reminder of the unpredictability of the timing and of the speed by which the pandemic situation can change,&quot; he said.
&lt;p&gt;
&lt;p&gt;&lt;a href=&quot;http://www.medpagetoday.com/InfectiousDisease/SwineFlu/&quot; title=&quot;Swine Flu Coverage&quot;&gt;&lt;img src=&quot;/images/swine.jpg&quot; border=&quot;0&quot;&gt;&lt;/a&gt;

    </recommendedItem>
    <recommendedItem id="20090101_19_4102"
                     title="Some Pediatric H1N1 Vaccine Recalled"
                     score="-0.006"
                     href="http://www.medpagetoday.com/InfectiousDisease/URItheFlu/tb/17557?impressionId=1265793570958"
                     
      &lt;p&gt;Sanofi Pasteur has recalled about 800,000 pediatric doses of its vaccine against pandemic H1N1 influenza because of low potency, the CDC announced, but the agency is not calling for revaccinations.&lt;/p&gt;
&lt;p&gt;The recalled doses come from four lots of 0.25-mL prefilled syringes for pediatric use in both 10-packs (lot numbers UT023DA, UT028DA, and UT028CB) and 25-packs (lot number UT030CA).&lt;/p&gt;
&lt;p&gt;The recall does not affect any of the vaccine for adults or products from other manufacturers.&lt;/p&gt;
&lt;p&gt;According to the CDC, &quot;There are no safety concerns with these lots of H1N1 vaccine. All lots successfully passed prerelease testing for purity, potency, and safety.&quot;&lt;/p&gt;
&lt;p&gt;The strength of vaccines can sometimes decline with time, the agency said in a statement on its Web site.&lt;/p&gt;
&lt;p&gt;Children who were vaccinated with the weakened doses should not be revaccinated because the antigen content &quot;is only slightly below the &apos;specified&apos; range,&quot; the CDC said. That level is still expected to be protective.&lt;/p&gt;
&lt;p&gt;In general, immunization experts did not seem overly concerned with the recall.&lt;/p&gt;
&lt;p&gt;&quot;When there will be over 150 million doses available in the U.S. alone, we should be happy that testing is vigorous and found very little problem thus far,&quot; Peter Katona, MD, of the University of California Los Angeles, wrote in an e-mail. &quot;The fact that revaccination isn&apos;t even recommended makes this even less of an issue.&quot;&lt;/p&gt;
&lt;p&gt;John Treanor, MD, of the University of Rochester in New York, said in an e-mail that &quot;a 10% drop in potency would mean, effectively, instead of getting a dose of 15 &amp;#181;g a person would be getting a dose of 13.5 &amp;#181;g.&quot;&lt;/p&gt;
&lt;p&gt;&quot;In studies that we and others have done with seasonal vaccine in adults, there is no substantial difference in the immune response between a dose of 15 &amp;#181;g and one of 7.5 &amp;#181;g, so I can&apos;t imagine that the effect of a 10% decrease in potency of this vaccine would be even noticeable,&quot; he said.&lt;/p&gt;

&lt;p&gt;Stephen Morse, PhD, of Columbia, said in an e-mail, &quot;I suspect most of the consequences [of the recall] will be perceptual, but it does add to the embarrassment in a program whose glitches have already been well publicized.&quot;&lt;/p&gt;

&lt;p&gt;The weakened potency of the vaccine doses was identified by Sanofi Pasteur during routine quality assurance testing, and the company has not yet determined the cause.&lt;/p&gt;
&lt;p&gt;Representatives from the company were not immediately available for comment.&lt;/p&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>
