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    <recommendedItem id="20100101_19_414"
                     title="H1N1 Vaccination Still a Good Idea, CDC Says"
                     score="0.013"
                     href="http://www.medpagetoday.com/InfectiousDisease/SwineFlu/tb/18325?impressionId=1265761585377"
                     
      &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="0.01"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/EnvironmentalHealth/tb/18228?impressionId=1265761585377"
                     
      &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_344"
                     title="FDA Revises HIV Drug Label for Liver Complication"
                     score="0.009"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18229?impressionId=1265761585377"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has updated labels of the HIV drug didanosine (Videx and Videx EC) to include warnings for potentially serious liver damage.&lt;/p&gt;
&lt;p&gt;Although these cases are rare, the drug may cause noncirrhotic hypertension in patients, a potentially fatal complication which the FDA discovered through 42 postmarket, adverse event reports.&lt;/p&gt;
&lt;p&gt;Of those patients, three required liver transplant and four died. Two deaths were caused by esophageal hemorrhage, while two more were caused by progressive liver failure.&lt;/p&gt;
&lt;p&gt;One patient suffered multiorgan failure, cerebral hemorrhage, sepsis, and lactic acidosis.&lt;/p&gt;
&lt;p&gt;The FDA said in a statement that it chose not to recall the drug because it believes its benefits outweigh potential risks, but advised that treatment decisions be made on an individual basis between healthcare professionals and patients.&lt;/p&gt;
&lt;p&gt;The agency added that causal association is difficult to determine in postmarket reports, but that alternative causes of the hypertension were ruled out in well-documented cases.&lt;/p&gt;
&lt;p&gt;Healthcare professionals who determine didanosine is effective in treating a patient should monitor that patient for the development of portal hypertension and esophageal varices, the agency said.&lt;/p&gt;
&lt;p&gt;Didanosine is used in combination with other HIV medications to help maintain CD4 cells in patients.&lt;/p&gt;
&lt;p&gt;The drug already has a black box warning for lactic acidosis and hepatomegaly with steatosis.&lt;/p&gt;
&lt;p&gt;Like the antiretroviral agents hydroxyurea and ribavirin, didanosine has been associated with the development of liver toxicity.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_302"
                     title="WHO Calls H1N1 Response Imperfect"
                     score="0.005"
                     href="http://www.medpagetoday.com/InfectiousDisease/SwineFlu/tb/18165?impressionId=1265761585377"
                     
      &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="20100101_19_160"
                     title="CDC Says 20% of Americans Got H1N1 Flu Shot"
                     score="-0.005"
                     href="http://www.medpagetoday.com/InfectiousDisease/SwineFlu/tb/17990?impressionId=1265761585377"
                     
      &lt;p&gt;As 2009 ended, an estimated 55 million Americans had been infected with the H1N1 pandemic flu and roughly one in five Americans had been vaccinated against the disease, the CDC said.&lt;/p&gt;
&lt;p&gt;The immunization data works out to about 61 million people, the agency said in an early release issue of &lt;em&gt;Morbidity and Mortality Weekly Report&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;The proportion of people vaccinated was higher among those in priority groups, the agency said, including 29.4% of children ages 6 months through 18 years and 38% of pregnant women.&lt;/p&gt;
&lt;p&gt;At the same time, the CDC issued new estimates of the toll taken by the pandemic virus since the outbreak began last April: &lt;ul&gt; &lt;li&gt;About 55 million people had been infected up to Dec. 12, although the estimates ranged from 39 million to as high as 80 million.&lt;/li&gt; &lt;li&gt;About 246,000 needed inpatient care, although the number ranged from 173,000 to 362,000. &lt;/li&gt; &lt;li&gt;And about 11,160 died, with the estimate ranging from 7,880 to 16,460.&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The vaccination findings are based on two surveys  --  the National 2009 H1N1 Flu Survey and the Behavioral Risk Factor Surveillance System survey, which took place from Dec. 27 to Jan. 2 and from Dec. 1 to 27, respectively.&lt;/p&gt;
&lt;p&gt;Because vaccine was expected to be in short supply at the beginning, the CDC established initial target groups, including pregnant women, people living with or caring for infants under 6 months, healthcare and emergency medical services personnel, children and young adults, and adults with certain medical conditions.&lt;/p&gt;
&lt;p&gt;The CDC estimated that 27.9% of those people got vaccinated.&lt;/p&gt;
&lt;p&gt;The agency said the vaccine supply is now &quot;ample&quot; and efforts to promote general vaccination should continue.&lt;/p&gt;

    </recommendedItem>
</recommendedContent>
