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    <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=1265737526856"
                     
      &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_769"
                     title="AAAAI: Food Allergies Among Hottest Topics at Meeting"
                     score="-0.005"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAAAI/tb/13255?impressionId=1265737526856"
                     
      WASHINGTON, March 13 -- New findings on food allergies will be a major focus for attendees at this year&apos;s meeting of the American Academy of Allergy, Asthma, and Immunology (AAAAI).
              &lt;p&gt; 
              &lt;p&gt;In addition to novel potential treatments with immunomodulators and other agents, research on the impact of food allergies on quality of life is also slated for presentation.
              &lt;p&gt; 
              &lt;p&gt;New diagnostic techniques to pinpoint the source of food allergies are also in the pipeline.
              &lt;p&gt; 
              &lt;p&gt;Also on the AAAAI schedule: 
              &lt;ul&gt; 
              &lt;li&gt; Presentation of a dozen new studies of sublingual immunotherapies to foster tolerance of pollens and other aeroallergens, potentially bringing this mode of treatment closer to clinical adoption in the U.S.
              &lt;li&gt; New findings on primary immunodeficiency, including a report on the potential dangers of routine infant vaccinations in babies with undetected immunodeficiency syndromes 
              &lt;li&gt; Promising approaches to patient and parental education on asthma
              &lt;/ul&gt; 
              &lt;p&gt;Scientific sessions begin tomorrow and &lt;em&gt;MedPage Today&lt;/em&gt; will bring you the highlights. 
        
    </recommendedItem>
    <recommendedItem id="20090101_19_784"
                     title="AAAAI: Oral Immunotherapy Beats Peanut Allergy in Some Children"
                     score="-0.005"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAAAI/tb/13272?impressionId=1265737526856"
                     
      WASHINGTON, March 16 -- Five of nine peanut-allergic children undergoing long-term, steady exposure to small quantities of peanuts are now able to eat peanut products freely, a researcher said here.
              &lt;br&gt; 
              &lt;br&gt;The children, enrolled in an open-label trial of oral immunotherapy for peanut allergy, have been treated for at least 2.5 years, A. Wesley Burks, M.D., of Duke University, reported at the American Academy of Allergy, Asthma, and Immunology meeting here.
              &lt;br&gt; 
              &lt;br&gt;The findings provide a glimmer of hope for up to 3 million Americans who suffer from peanut allergies in a society where peanut products are ubiquitous.
              &lt;p&gt; 
              &lt;p&gt;Peanut allergies are among the most common triggers of anaphylaxis, according to the AAAAI, and only one in five children with the allergy outgrows it in adulthood.
              &lt;p&gt; 
              &lt;p&gt;Currently, the standard treatment is avoidance of foods containing the legumes and keeping an epinephrine injector close by to deal with severe reactions.
              &lt;p&gt; 
              &lt;p&gt;In all, 39 children have participated in the ongoing study, which Dr. Burks characterized as an open-label pilot trial.
              &lt;p&gt; 
              &lt;p&gt;The ongoing study protocol -- with 33 currently enrolled -- began when children were two to five years old. They initially received tiny doses of peanut flour, less than one milligram.
              &lt;p&gt; 
              &lt;p&gt;The children took steadily increasing amounts of peanut until, eight to ten months later, they could tolerate up to 15 peanuts per day.
              &lt;p&gt; 
              &lt;p&gt;Treatment continued at that level, Dr. Burks said, with periodic challenges to confirm the youngsters&apos; ability to tolerate peanut products.
              &lt;p&gt; 
              &lt;p&gt;The researchers -- including scientists at the University of Arkansas in Little Rock -- have determined that children successfully treated showed significantly decreased serum levels of peanut-specific immunoglobulin E.
              &lt;p&gt; 
              &lt;p&gt;Withdrawal of the immunotherapy has now begun to be tested in participants with very low peanut IgE, less than 2 kU/L.
              &lt;p&gt; 
              &lt;p&gt;Five of nine children who had been on treatment for at least 2.5 years passed an oral food challenge test. Researchers then stopped their immunotherapy for a month, followed by a second challenge test.
              &lt;p&gt; 
              &lt;p&gt;It was successful in all cases, Dr. Burks said, and the children now are under no diet restrictions and eat peanut-containing foods daily. &quot;They are months out and they are doing fine,&quot; he said.
              &lt;p&gt; 
              &lt;p&gt;Biochemical studies in these children indicate that the therapy induced regulatory T cells and secretion of IL-10 indicative of tolerance to peanut proteins.
              &lt;p&gt; 
              &lt;p&gt;&quot;They [immune cells] change to a nonallergic phenotype,&quot; Dr. Burks said.
              &lt;p&gt; 
              &lt;p&gt;Of the 39 total participants, six moved away and dropped out, and four withdrew because of allergic reactions.
              &lt;p&gt; 
              &lt;p&gt;Also underway is a separate double-blind, placebo-controlled study of the oral immunotherapy protocol, he added.
              &lt;p&gt; 
              &lt;p&gt;The study is still in its early stages, but data are available on 18 children participating in it.
              &lt;p&gt; 
              &lt;p&gt;The children are one to 16 years old and have completed one year in the study. Among 12 assigned to active therapy, the mean tolerance at one year was 15 peanuts, compared with 1.5 peanuts for six placebo-group children (&lt;em&gt;P&lt;/em&gt;&lt;0.05), Dr. Burks said.
              &lt;p&gt; 
              &lt;p&gt;Recruitment in the placebo-controlled study is also continuing.
              &lt;p&gt; 
              &lt;p&gt;Dr. Burks said he thinks some form of oral immunotherapy for peanut allergy will be available for clinical use within a few years. Until such issues as dosing and duration of treatment are established with more patients, though, he strongly cautioned against clinicians or parents plunging ahead on their own.
              &lt;p&gt; 
              &lt;p&gt;Commenting on the Duke-Arkansas research, Robert Wood, M.D., professor of pediatrics at Johns Hopkins University, called the results encouraging. But he was more pessimistic about the time frame, predicting that it probably would be &quot;more than 10 years&quot; before an FDA-approved clinical treatment is available.
              &lt;p&gt; 
              &lt;p&gt;&lt;table cellspacing=&quot;0&quot; hspace=&quot;1&quot; style=&quot;border-style:solid; border-width:1px; border-color:#8dabbc; font-family:arial; font-size:12px; background-color:#DBE9F2; padding:5px 5px 5px 5px;&quot;&gt;
&lt;tr&gt;&lt;td&gt;The studies were funded by the National Institutes of Health, the Food Allergy and Anaphylaxis Network, the Food Allergy Project, Gerber Foundation, and the Robins Family Foundation.
              &lt;p&gt; 
              &lt;p&gt;Dr. Burks reported relationships with Acto-GeniX NV, Allertein, Dannon Co. Probiotics, EpiPen/Dey L.P., Genentech, Novartis, Nutricia, McNeil Nutritionals, Mead Johnson, MastCell Inc., and Gerber.&lt;/td&gt;&lt;/tr&gt;&lt;/table&gt;
           
    </recommendedItem>
    <recommendedItem id="20090101_19_789"
                     title="AAAAI: Travel Difficult for People with Food Allergies"
                     score="-0.005"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAAAI/tb/13276?impressionId=1265737526856"
                     
      WASHINGTON, March 16 -- When members of a family have food allergies, vacation planning often requires significant effort to minimize risks, researchers said here.
              &lt;p&gt; 
              &lt;p&gt;More than 90% of such families have packed their own food when they go on vacation, and have mapped out locations of hospitals at their destinations, reported Scott Sicherer, M.D., of Mount Sinai School of Medicine in New York, at the American Academy of Allergy, Asthma, and Immunology meeting here.
              &lt;p&gt; 
              &lt;p&gt;His data emerged from a survey of 410 attendees of conferences sponsored by the Food Allergy and Anaphylaxis Network, a nonprofit advocacy and support group.
              &lt;p&gt; 
              &lt;p&gt;&quot;Food allergies limit where and how families with food-allergic individuals vacation,&quot; Dr. Sicherer said.
              &lt;p&gt; 
              &lt;p&gt;Although 94% of respondents said they still take vacations, about three-quarters indicated that they chose destinations on the basis of available medical care.
              &lt;p&gt; 
              &lt;p&gt;Some 80% have avoided cruises for that reason, the survey found.
              &lt;p&gt; 
              &lt;p&gt;In addition, 90% have not left the U.S., in part because of issues involving the availability of medical care and in part because of unfamiliar foods that might trigger reactions.
              &lt;p&gt; 
              &lt;p&gt;Food allergies affecting participants&apos; families included peanuts (85%), tree nuts (69%), egg (48%), dairy (45%), and shellfish (24%).
              &lt;p&gt; 
              &lt;p&gt;Other findings from the survey included:
              &lt;p&gt; 
              &lt;ul&gt;
                &lt;li&gt;65% have tried to avoid air travel, primarily because of potential peanut exposure
                &lt;li&gt;53% have requested special airplane accommodations
                &lt;li&gt;65% carried extra medical documentation
                &lt;li&gt;67% obtained extra epinephrine injectors
                &lt;li&gt;51% ate most meals in their own rooms
                &lt;li&gt;86% arranged for special meals at restaurants
                &lt;li&gt;82% said arranging special meals was not difficult
              &lt;/ul&gt;
              &lt;p&gt; 
              &lt;p&gt;Dr. Sicherer said that for families with members who have food allergies leaving home means &quot;you&apos;re talking about a lot of detailed information to deal with, a lot of potential anxiety with everything that goes on all day. It&apos;s like living in a minefield.&quot;
              &lt;p&gt; 
              &lt;p&gt;Vacation planning is just one of the many effects food allergies have on quality of life, he said.
              &lt;p&gt; 
              &lt;p&gt;Robert Wood, M.D., a pediatric allergist at Johns Hopkins University in Baltimore, a discussant at the session who was not involved in the study, commented that food allergy incidence in children, and eventually in adults as well, appears to be rising.
              &lt;p&gt; 
              &lt;p&gt;Food allergy &quot;may be a different disease now,&quot; he said. Some allergies that formerly seemed to be confined mainly to children are now persisting more frequently into adulthood, he said.
              &lt;p&gt; 
              &lt;p&gt; 
              &lt;p&gt;&lt;table cellspacing=&quot;0&quot; hspace=&quot;1&quot; style=&quot;border-style:solid; border-width:1px; border-color:#8dabbc; font-family:arial; font-size:12px; background-color:#DBE9F2; padding:5px 5px 5px 5px;&quot;&gt;
&lt;tr&gt;&lt;td&gt;The study was funded by the Food Allergy and Anaphylaxis Network.
              &lt;p&gt; 
              &lt;p&gt;Dr. Sicherer reported no potential conflicts of interest.
              &lt;p&gt;Dr. Wood reported serving on the advisory board of Dey.&lt;/td&gt;&lt;/tr&gt;&lt;/table&gt;
             
    </recommendedItem>
    <recommendedItem id="20090101_19_823"
                     title="AAAAI: Allergen Labels May Not Predict Food Content"
                     score="-0.005"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAAAI/tb/13318?impressionId=1265737526856"
                     
      WASHINGTON, March 18 -- Allergen advisory labels are a poor guide to whether the food inside the package may cause reactions in consumers with food allergies, researchers said here.
              &lt;p&gt; 
              &lt;p&gt;Tests of 367 commercial products for the presence of egg and milk found seven with no allergen disclosure that they, in fact, contained one or both substances, Scott Sicherer, M.D., of Mount Sinai School of Medicine in New York, reported.
              &lt;p&gt; 
              &lt;p&gt;Meanwhile, a separate study at the University of Nebraska found that terms used to describe the possible presence of milk fat or protein (such as &quot;may contain&quot; or &quot;produced in a facility that also processes milk products&quot;) do not necessarily correlate with the likelihood of actual milk presence.
              &lt;p&gt; 
              &lt;p&gt;Some products listed as possibly containing milk residues tested negative, the Nebraska researchers found.
              &lt;p&gt; 
              &lt;p&gt;Both studies were presented here at the American Academy of Allergy, Asthma, and Immunology meeting.
              &lt;p&gt; 
              &lt;p&gt;Dr. Sicherer said the studies on labeling are necessary because of the variation in labeling terminology -- which is currently unregulated and voluntary -- and because recent research suggests that consumers are ignoring labels.
              &lt;p&gt; 
              &lt;p&gt;His study involved a total of 599 tests on 401 food products, assaying for peanut proteins as well as egg and milk. A variety of processed food products were obtained from supermarket shelves.
              &lt;p&gt; 
              &lt;p&gt;None of the products had egg, milk, or peanut listed as ingredients. But labels said the products &quot;may contain&quot; these allergens. The researchers also selected an equal or greater number of similar-looking products with no warnings or advisories.
              &lt;p&gt; 
              &lt;p&gt;None of the 120 products without advisory labels contained detectable peanut residues. However, four out of 134 unlabeled products tested for milk came back positive. Likewise three of 117 unlabeled products tested positive for egg.
              &lt;p&gt; 
              &lt;p&gt;Among products with &quot;may contain&quot; labeling, 5.3% tested positive for one or more of the allergens, including 4.5% for peanut, 1.8% for egg, and 10.2% for milk.
              &lt;p&gt; 
              &lt;p&gt;The Nebraska study also found that milk was commonly present in products with a variety of labeling terms:
              &lt;p&gt; 
              &lt;ul&gt;
                &lt;li&gt;23 of 50 labeled as &quot;may contain milk&quot;
                &lt;li&gt;13 of 57 with &quot;shared equipment&quot; language
                &lt;li&gt;9 of 40 with &quot;shared facility&quot; language
                &lt;li&gt;16 of 29 with milk listed as a &quot;minor&quot; ingredient
                &lt;li&gt;1 of 3 with other labeling terminology
              &lt;/ul&gt;
              &lt;p&gt; 
              &lt;p&gt;The study tested 185 samples of 100 different commercial food products, according to Matthew Crotty, an undergraduate at the university who presented the findings here.
              &lt;p&gt; 
              &lt;p&gt;Some of the milk doses were substantial. Products containing more than 90 mg of milk components per suggested serving were found in each of the &quot;may contain,&quot; &quot;shared equipment,&quot; and &quot;shared facility&quot; labeling categories.
              &lt;p&gt; 
              &lt;p&gt;In the &quot;minor ingredient&quot; category, products containing up to 24 mg of milk per serving were found.
              &lt;p&gt; 
              &lt;p&gt;Highly sensitive individuals may react to submilligram doses of milk.
              &lt;p&gt; 
              &lt;p&gt;The study also found that dark chocolate candies contain gram amounts of milk per serving, thousands of times the dose necessary to trigger reactions in sensitive individuals.
              &lt;p&gt; 
              &lt;p&gt;These candies all listed milk fat as an ingredient on their labels, but many consumers might not think to look for it in a dark chocolate product, Crotty said.
              &lt;p&gt; 
              &lt;p&gt;Dr. Sicherer said manufacturers should do more internal testing to guide their product labeling. He also called for regulations restricting advisory labels to those products that actually contain allergens or residues.
              &lt;p&gt; 
              &lt;p&gt;Robert Wood, M.D., a pediatric allergist at Johns Hopkins in Baltimore, who was not involved in either study, said the two reports help document the &quot;inadequacy, inconsistency, [and] confusion for patients and their caretakers&quot; resulting from current labels.
              &lt;p&gt; 
              &lt;p&gt;He noted that federal regulations are on the way, in the wake of a hearing sponsored by the FDA last September. But he said it was unclear how much any government-mandated labeling requirements will help severely allergic patients and their families.
              &lt;p&gt; 
              &lt;p&gt;In making recommendations to the FDA, Dr. Wood said, physicians &quot;look out for our most sensitive patients, the ones who would react to a really trivial exposure.&quot;
              &lt;p&gt; 
              &lt;p&gt;&quot;The really difficult part of this is, what threshold do you act upon? Do you act upon that most sensitive patient? Or do you protect 99%, 98%, or 95%?&quot;
              &lt;p&gt; 
              &lt;p&gt;He pointed out that if the goal is to protect the most sensitive individuals, &quot;then you may have more warning labels than we have already. You may know what they mean, more than we do right now, but it may not make buying food off the shelf any easier.&quot;
              &lt;p&gt; 
              &lt;p&gt;&lt;table cellspacing=&quot;0&quot; hspace=&quot;1&quot; style=&quot;border-style:solid; border-width:1px; border-color:#8dabbc; font-family:arial; font-size:12px; background-color:#DBE9F2; padding:5px 5px 5px 5px;&quot;&gt;
&lt;tr&gt;&lt;td&gt;Dr. Sicherer&apos;s study was funded by the Food and Allergy Initiative. No external funding was reported for the Nebraska study.
              &lt;p&gt; 
              &lt;p&gt;Dr. Sicherer and Crotty reported no potential conflicts of interest. Dr. Wood reported a relationship with Dey.&lt;/td&gt;&lt;/tr&gt;&lt;/table&gt;
              
    </recommendedItem>
</recommendedContent>
