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    <recommendedItem id="20100101_19_414"
                     title="H1N1 Vaccination Still a Good Idea, CDC Says"
                     score="0.012"
                     href="http://www.medpagetoday.com/InfectiousDisease/SwineFlu/tb/18325?impressionId=1265796538325"
                     
      &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="0.009"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/EnvironmentalHealth/tb/18228?impressionId=1265796538325"
                     
      &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="20100101_19_302"
                     title="WHO Calls H1N1 Response Imperfect"
                     score="0.004"
                     href="http://www.medpagetoday.com/InfectiousDisease/SwineFlu/tb/18165?impressionId=1265796538325"
                     
      &lt;p&gt;The World Health Organization says its response to the H1N1 pandemic could have been better, but was not unduly swayed by drug manufacturers.&lt;/p&gt;
&lt;p&gt;&quot;We are under no illusions that this response was the perfect response,&quot; Keiji Fukuda, MD, the agency&apos;s top flu expert, told a hearing being held by the Council of Europe&apos;s health committee.&lt;/p&gt;
&lt;p&gt;But he added, &quot;The influenza pandemic policies and responses recommended and taken by WHO were not improperly influenced by the pharmaceutical industry.&quot;&lt;/p&gt;
&lt;p&gt;The council&apos;s hearing is a response to criticism by some European politicians, as well as elements of the media, that the danger of the H1N1 pandemic was exaggerated, perhaps to allow drug companies to score multimillion-dollar contracts for vaccines and antivirals.&lt;/p&gt;
&lt;p&gt;In North America, many experts defended the response to the outbreak, which WHO last April declared a phase six pandemic  --  the highest level. The phases reflect that an infectious agent is widely spread and causing disease in the community, but they say nothing about the severity of the disease.&lt;/p&gt;
&lt;p&gt;&quot;I do not believe that the record supports the claim that health officials in the U.S. or WHO exaggerated the threat,&quot; said Andy Pavia, MD, of the University of Utah in Salt Lake City.&lt;/p&gt;
&lt;p&gt;Pavia said in an e-mail that health officials had a choice  --  to assume the threat was minor or to react strongly.&lt;/p&gt;
&lt;p&gt;&quot;The choice is obvious,&quot; Pavia said, &quot;and I would not want to be in a position of explaining to the families of victims why we planned for the mildest outcome.&quot;&lt;/p&gt;
&lt;p&gt;For the most part, illness caused by the disease has been mild, although several thousand people have died around the world and many more were sick enough to require intensive care.&lt;/p&gt;
&lt;p&gt;But the relatively low number of deaths has prompted Wolfgang Wodarg, MD, a German member of the council&apos;s Parliamentary Assembly, to dub the outbreak a &quot;false pandemic&quot; and call for this week&apos;s hearing.&lt;/p&gt;
&lt;p&gt;&quot;What we have experienced now is that millions of people have been vaccinated unnecessarily,&quot; Wodarg said. &quot;This is damage done to people, in order to earn money.&quot;&lt;/p&gt;
&lt;p&gt;Fukuda, on the other hand, said today the pandemic &quot;is a scientifically well-documented event.&quot;&lt;/p&gt;
&lt;p&gt;&quot;The labeling of the pandemic as &quot;fake&quot; is to ignore recent history and science,&quot; he said, &quot;and to trivialize the deaths of over 14,000 people and the many additional serious illnesses experienced by others.&quot;&lt;/p&gt;
&lt;p&gt;Utah&apos;s Pavia echoed that sentiment. Ask any front-line doctor if the H1N1 flu was mild, he said, &quot;and prepare to get your head handed to you.&quot;&lt;/p&gt;
&lt;p&gt;One of them was Daniel Hinthorn, MD, of the University of Kansas Medical Center in Kansas City, Kan. &quot;As a physician who saw many patients with this disease, I believe it was very serious in many people,&quot; he wrote in an e-mail. &quot;The threat was not exaggerated, at least to my mind.&quot;&lt;/p&gt;
&lt;p&gt;Even last month, as flu activity in the U.S. declined, he said his hospital treated 11 inpatients for the flu, including six in intensive care, while &quot;lots of others&quot; were being seen in emergency wards and clinics.&lt;/p&gt;
&lt;p&gt;On the other hand, to say the threat was exaggerated &quot;is merely to say the obvious,&quot; argued Philip Alcabes, PhD, of City University of New York City. By the time a vaccine was available, &quot;this outbreak was far less serious than feared,&quot; he said in an e-mail.&lt;/p&gt;
&lt;p&gt;But &quot;reality-based skepticism about swine flu&quot; doesn&apos;t mean that people would refuse immunization  --  not if an outbreak was a real public danger, caused by a &quot;highly transmissible agent, likely to be virulent, highly preventable with reliably effective vaccine.&quot;&lt;/p&gt;
&lt;p&gt;He warned that public health professionals must avoid &quot;falling in love with the most dire forecast and then pushing high-tech precautions against the worst-case scenario.&quot;&lt;/p&gt;
&lt;p&gt;When that happens, &quot;people have to be excused for wondering whether the officials, the media, and the pharmaceutical companies were in cahoots on swine flu,&quot; he said.&lt;/p&gt;
&lt;p&gt;But several experts argued that preparing for a worst-case scenario was the responsible thing to do.&lt;/p&gt;
&lt;p&gt;Sometimes, &quot;mother nature throws us a break,&quot; argued Howard Markel, MD, PhD, of the University of Michigan in Ann Arbor.&lt;/p&gt;
&lt;p&gt;&quot;We responded to a threat without knowing the future,&quot; he said in an e-mail. &quot;A far worse outcome might have occurred if we did not take the threat seriously and H1N1 turned out to be worse than we initially predicted.&quot;&lt;/p&gt;
&lt;p&gt;The public health response should be compared to the use of seat belts or auto insurance, according to Gregory Poland, MD, of the Mayo Clinic in Rochester, Minn.&lt;/p&gt;
&lt;p&gt;Every day, he said in an e-mail, he puts on his seat belt before driving. &quot;I don&apos;t finish each day and say &apos;What a waste, I didn&apos;t have an accident,&apos;&quot; he said.&lt;/p&gt;
&lt;p&gt;&quot;It is (and remains) unpredictable as to whether this virus could further mutate or change in a manner such that it could literally turn deadly within weeks,&quot; he said. &quot;If this pandemic had been deadly (and you don&apos;t know until you are into it) and we weren&apos;t prepared, the criticism would have been overwhelming.&quot; Poland said.&lt;/p&gt;
&lt;p&gt;He and others also noted that the flu season isn&apos;t over yet.&lt;/p&gt;
&lt;p&gt;&quot;This argument should be taking place at the end of the flu season in late March, not now,&quot; said Peter Katona, MD, of the University of California Los Angeles. &quot;Flu is unpredictable, and this is the heart of the argument.&quot;&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>
    <recommendedItem id="20090101_19_1294"
                     title="IVW: Pandemic Vaccines May be Too Little, Too Late"
                     score="-0.005"
                     href="http://www.medpagetoday.com/InfectiousDisease/SwineFlu/tb/13943?impressionId=1265796538325"
                     
      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_1613"
                     title="H1N1 Strain May Have Been Undetected in Pigs for Years"
                     score="-0.005"
                     href="http://www.medpagetoday.com/InfectiousDisease/SwineFlu/tb/14352?impressionId=1265796538325"
                     
       TORONTO, May 22 -- The novel H1N1 flu virus may have been propagating in pigs for years without being detected, according to researchers who studied the genetic sequences of more than 70 samples isolated from patients in Mexico and the U.S.  
              &lt;p&gt; 
              &lt;p&gt;It&apos;s likely that other novel strains have also emerged but have not been noticed, according to Rebecca Garten, Ph.D., of the CDC and colleagues.
              &lt;p&gt; 
              &lt;p&gt;The circumstances that led to the development of the current novel strain and its emergence from animal hosts to cause human disease remain unknown, Dr. Garten and colleagues said online today in &lt;em&gt;Science&lt;/em&gt;.
              &lt;p&gt; 
              &lt;p&gt;But the &quot;relative lack of surveillance for swine influenza viruses&quot; -- combined with molecular evidence of the ancestry of the genes in the current strain -- &quot;suggests that this virus might have been circulating undetected among swine herds somewhere in the world,&quot; they said.
              &lt;p&gt; 
              &lt;p&gt;The current novel strain is a so-called triple reassortant -- meaning it has genes from pig, bird, and human flu.
              &lt;p&gt; 
              &lt;p&gt;But while such reassortants have been circulating in pigs for several years, the precise combination of genes in the current strain had not previously been detected, according to Nancy Cox, Ph.D., director of the CDC&apos;s influenza division and one of the authors of the &lt;em&gt;Science&lt;/em&gt; paper.
              &lt;p&gt; 
              &lt;p&gt;That could be because surveillance of pig flu viruses in the U.S. &quot;is not very systematic&quot; and elsewhere is even less so, Dr. Cox said in a telephone press conference.
              &lt;p&gt; 
              &lt;p&gt;Animal flu researchers around the world, she said, are now going back through their stored samples to see if they can find the &quot;missing link&quot; between known reassortant viruses and the current H1N1 strain.
              &lt;p&gt; 
              &lt;p&gt;She added that the gap in knowledge points out the &quot;global need&quot; for a closer watch on animal viruses.
              &lt;p&gt; 
              &lt;p&gt;Dr. Cox said all influenza genes ultimately derive from avian flu, but they can swap around among hosts.
              &lt;p&gt; 
              &lt;p&gt;In this case, all of the genes in the current strain are found in pigs, although one -- the polymerase basic B gene -- is recently derived from a human flu strain and two others are recently derived from birds.
              &lt;p&gt; 
              &lt;p&gt;H1N1 viruses were first isolated from pigs in 1930 and are highly similar to a reconstructed version of the human 1918 Spanish flu virus, which was also H1N1.
              &lt;p&gt; 
              &lt;p&gt;From then until the late 1990s, so-called &quot;classical swine influenza&quot; viruses circulated in pigs and remained relatively stable in terms of how they react with antibodies, Dr. Garten and colleagues said.
              &lt;p&gt; 
              &lt;p&gt;Meanwhile, H1N1 viruses circulated in humans until 1957 and then re-emerged in 1977 -- having changed significantly -- with the result that classical pig viruses and human H1N1 strains are now very different.
              &lt;p&gt; 
              &lt;p&gt;&quot;Pigs have become a reservoir of viruses with the potential to cause significant respiratory outbreaks or even a possible pandemic in humans,&quot; Dr. Garten and colleagues said.
              &lt;p&gt; 
              &lt;p&gt;The designation H1N1 refers to two surface proteins -- hemagglutinin and neuraminidase -- that serve to identify different varieties of the flu. But even within a category such as H1N1, the proteins can vary substantially, causing marked differences in how they interact with antibodies.
              &lt;p&gt; 
              &lt;p&gt;Antibodies to the currently circulating seasonal H1N1 flu -- derived from ferrets -- did not react with the novel strain, Dr. Garten and colleagues found. But humans have a more complex immune system than ferrets, so the tests aren&apos;t definitive proof that there&apos;s no cross-immunity.
              &lt;p&gt; 
              &lt;p&gt;On the other hand, while most people may not have antibodies to the virus, many of the molecular markers predicted to be associated with adaptation to a human host or to the generation of a pandemic virus haven&apos;t been found in the current strain.
              &lt;p&gt; 
              &lt;p&gt;For instance, the 1918 virus and the current avian H5N1 strains have a section of their NS1 protein that delivers enhanced virulence. But in the current H1N1 strain, the gene for that protein has a premature stop that eliminates that section. 
              &lt;p&gt; 
              &lt;p&gt;Other elements known to promote transmissibility and virulence are also missing, the researchers said, suggesting that previously unknown molecular factors are allowing the virus to spread in humans.
              &lt;p&gt; 
              &lt;p&gt;The tested isolates are very similar to each other in how they react to antibodies -- with less variation in the hemagglutinin gene that would be seen in a seasonal circulating strain -- and also similar to other swine viruses seen in recent years.
              &lt;p&gt; 
              &lt;p&gt;That implies, Dr. Cox said, that the viruses crossed into humans in either a single event or multiple events with very similar viruses. But where and when that took place remains a mystery, the researchers said.
              &lt;p&gt; 
              &lt;p&gt;The novel strain was first identified late in April, in two unrelated pediatric cases in San Diego, as an un-subtyped H1N1 virus.
              &lt;p&gt; 
              &lt;p&gt;Within days, experts were aware that a rash of influenza-like illness in Mexico was being caused by the novel virus, which has since caused more than 11,000 confirmed cases in 42 countries, according to the World Health Organization.
              &lt;p&gt; 
              &lt;p&gt;There have been 86 deaths from the illness, according to the WHO.
    </recommendedItem>
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