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    <recommendedItem id="20100101_19_344"
                     title="FDA Revises HIV Drug Label for Liver Complication"
                     score="0.007"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18229?impressionId=1265787632882"
                     
      &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_343"
                     title="U.S. Marshals Seize Unapproved Ozone Generators"
                     score="0.007"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/EnvironmentalHealth/tb/18228?impressionId=1265787632882"
                     
      &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_370"
                     title="Blocking Enzyme in Mice Reduces Fat (CME/CE)"
                     score="0.007"
                     href="http://www.medpagetoday.com/PrimaryCare/Obesity/tb/18259?impressionId=1265787632882"
                     
      &lt;p&gt;Blocking a single enzyme leads to increased energy expenditure and loss of body fat  --  at least in mice, researchers said.&lt;/p&gt;
&lt;p&gt;Mice treated with a compound that blocks the so-called Fyn kinase expended 14% more energy than animals treated with an inert compound, according to Claire Bastie, PhD, and colleagues at Albert Einstein College of Medicine in New York City.&lt;/p&gt;
&lt;p&gt;They also displayed a significant weight loss within 12 hours of receiving the compound, compared with animals given the inert substance, Bastie and colleagues reported in the Feb. 3 issue of &lt;em&gt;Cell Metabolism&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;&quot;This is a new mechanism to help the body to burn extra energy,&quot; Bastie said in a statement.&lt;/p&gt;
&lt;p&gt;The Fyn kinase has previously been linked to energy use: animals with the enzyme blocked burn more fatty acids and are leaner than their normal littermates, Bastie and colleagues noted.&lt;/p&gt;
&lt;p&gt;Those animals also had increased insulin sensitivity, the researchers said, but the absence of the enzyme did not block the normal anabolic processes of protein synthesis and muscle growth during the feeding cycle.&lt;/p&gt;
&lt;p&gt;The findings suggested that drugs blocking the enzyme might have a significant effect on energy balance and weight, they theorized.&lt;/p&gt;
&lt;p&gt;To test the idea, they turned to wild-type mice and a compound called SU6656, a known inhibitor of the Src family of tyrosine kinases, of which Fyn is a member.&lt;/p&gt;
&lt;p&gt;The mice spent spent 48 hours getting used to a so-called metabolic chamber, which allows researchers to monitor energy intake and expenditure. Then the compound was administered via intraperitoneal injection.&lt;/p&gt;
&lt;p&gt;Control animals got injections of an inert substance, the researchers said. The shots were given at the beginning of the light cycle, when the animals are least active.&lt;/p&gt;
&lt;p&gt;Both groups showed identical carbohydrate use during the dark cycle (when they are most active) that preceded the injection.&lt;/p&gt;
&lt;p&gt;After the injection, the control animals reduced energy use as their bodies switched to the normal lipid production seen during the light cycle.&lt;/p&gt;
&lt;p&gt;The treated animals, on the other hand, continued to expend energy at a rate that was significantly greater (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.0098) than the controls, although there was no significant difference in physical activity.&lt;/p&gt;
&lt;p&gt;Because mice eat 80% of their calories during the dark cycle, they have a daily pattern of weight loss and gain, Bastie and colleagues noted, so that 12 hours after the start of the light cycle  --  when they had been given the shots  --  their weight was lowest.&lt;/p&gt;
&lt;p&gt;But the SU6656-treated mice had a 40% greater weight loss than the control group, a difference that was significant at &lt;em&gt;P&lt;/em&gt;&amp;lt;0.003.&lt;/p&gt;
&lt;p&gt;Lean mass was slightly reduced in all the animals, Bastie and colleagues said, but without significant differences between groups. On the other hand, fat mass was significantly reduced (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05) in the SU6656-treated mice, they found.&lt;/p&gt;
&lt;p&gt;The metabolic effect of the inhibitor appears to be specific to Fyn, because it had no effect on mice lacking the enzyme, the researchers noted.&lt;/p&gt;
&lt;p&gt;Unfortunately, SU6656 itself isn&apos;t a good choice for clinical trials of the idea in humans, Bastie said, because the Fyn kinase affects the brain, as well as muscle and fat tissue.&lt;/p&gt;
&lt;p&gt;&quot;Our next goal,&quot; she said, &quot;is to design something extremely specific to muscle and adipose.&quot;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was supported by the Ellison Medical Foundation, the NIH, the American Diabetes Association, and the NY Obesity Research Center.&lt;/p&gt;&lt;p&gt;The researchers did not report any conflicts.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_369"
                     title="Administration Issues Mental Health Parity Rule"
                     score="0.007"
                     href="http://www.medpagetoday.com/Psychiatry/GeneralPsychiatry/tb/18258?impressionId=1265787632882"
                     
      &lt;p&gt;WASHINGTON  --  Under a proposed rule released by the Obama administration, patients in a group insurance plan who are being treated for mental illness or substance abuse may no longer be charged more than if they were receiving medical or surgical care.&lt;/p&gt;
&lt;p&gt;The Department of Health and Human Service (HHS), the Department of Labor, and the Internal Revenue Service issued an interim rule last week containing specific language necessary to enforce the bipartisan &lt;a href=&quot;http://www.medpagetoday.com/Psychiatry/GeneralPsychiatry/11169&quot; mce_href=&quot;http://www.medpagetoday.com/Psychiatry/GeneralPsychiatry/11169&quot; target=&quot;_blank&quot; title=&quot;Financial&amp;#8200;Bailout&amp;#8200;Carries&amp;#8200;Mental&amp;#8200;Health&amp;#8200;Parity&amp;#8200;Bill&amp;#8200;Through&amp;#8200;Congress&quot;&gt;mental health parity law passed by Congress in 2008&lt;/a&gt;.&lt;/p&gt;
&lt;p&gt;The law  --  called the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act  --  states that if a group health plan covers the treatment of mental illness or drug or alcohol abuse, the limits and financial requirements for these services can be &quot;no more restrictive&quot; than those that apply to medical and surgical benefits.&lt;/p&gt;
&lt;p&gt;That means an insurance plan cannot charge higher copayments, deductibles, and out-of-pocket expenses for mental health services than for treatment of physical illnesses.&lt;/p&gt;
&lt;p&gt;Companies with fewer than 50 employees in their group insurance plans are excluded from the law.&lt;/p&gt;
&lt;p&gt;&quot;The rules we are issuing today will, for the first time, help assure that those diagnosed with these debilitating and sometimes life-threatening disorders will not suffer needless or arbitrary limits on their care,&quot; said Kathleen Sebelius, secretary of HHS.&lt;/p&gt;

&lt;p&gt;The American Psychiatric Association (APA) issued a statement applauding the regulations.&lt;/p&gt;
    &lt;p&gt;&quot;Mental health parity was a major advance for the APA and for our patients living with mental illnesses,&quot; according to the group&apos;s president, Alan F. Schatzberg, MD. &quot;The APA will continue to work hard and submit the important feedback to the administration that is necessary to make sure our patients receive the care they need.&quot;&lt;/p&gt;
    &lt;p&gt;The statement also drew attention to some shortcomings in the regulations, which did not address provider networks and formulary development.&lt;/p&gt;
    &lt;p&gt;The APA intends to submit recommendations for these and other topics during the 90-day comment period.&lt;/p&gt;
    &lt;p&gt;The American Psychological Association also welcomed the regulations.&lt;/p&gt;
    &lt;p&gt;&quot;We are delighted that under these regulations consumers are protected from insurance discrimination to the greatest extent possible,&quot; according to its executive director for professional practice, Katherine Nordal, PhD, in a prepared statement.&lt;/p&gt;
    &lt;p&gt;The rule also requires a single deductible for mental health and medical/surgical coverage. Patients who are being treated for a mental condition at the same time as somatic condition often have to pay separate deductibles which can &quot;prevent access to mental health treatment,&quot; according to the psychologists&apos; group.&lt;/p&gt;
    &lt;p&gt;&quot;It is particularly significant that the regulation will ban health plans from imposing separate deductibles or setting separate out-of-pocket caps for mental health and medical/surgical services,&quot; the statement said. &quot;This is a big win for anyone seeking mental health treatment.&quot;&lt;/p&gt;
    &lt;p&gt;The 2008 law expanded greatly on the Mental Health Parity Act of 1996, which required parity only in lifetime and annual dollar limits. In practice, crtics say, insurers got around that prohibition by charging higher copayments for mental health services and by &quot;cherry-picking&quot; services that would and would not be covered.&lt;/p&gt;
    &lt;p&gt;The 1996 law also specifically excluded coverage parity for substance abuse treatment.&lt;/p&gt;
    &lt;p&gt;The new rule will take effect April 5, 2010.

    </recommendedItem>
    <recommendedItem id="20100101_19_301"
                     title="Tight Glucose Control Fails in Septic Shock (CME/CE)"
                     score="0.001"
                     href="http://www.medpagetoday.com/CriticalCare/Sepsis/tb/18160?impressionId=1265787632882"
                     
      Septic shock patients treated with a corticosteroid get no survival advantage from tight glucose control or addition of a second corticosteroid to provide more mineralocorticoid activity, according to results of a randomized trial.&lt;br&gt;
&lt;br&gt;Aiming for normoglycemia at 80 to 110 mg/dL rather than the standard 150 mg/dL had no impact on inhospital mortality rates (45.9% versus 42.9%, &lt;em&gt;P&lt;/em&gt;=0.50), Djillali Annane, MD, of H&amp;#244;pital Raymond Poincar&amp;#233; in Garches, France, and colleagues found.&lt;br&gt;
&lt;br&gt;Inhospital mortality was likewise similar whether patients got hydrocortisone (Solu-Cortef) alone or with the addition of fludrocortisone ([Florinef] 42.9% versus 45.8%, &lt;em&gt;P&lt;/em&gt;=0.50), they reported in the Jan. 27 issue of the &lt;em&gt;Journal of the American Medical Association&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;This aggressive treatment strategy should not be routine, the researchers recommended.&lt;/p&gt;
&lt;p&gt;These findings largely match the general lack of benefit seen with tight glycemic control in recent studies with ICU patients overall.&lt;/p&gt;
&lt;p&gt;The prematurely terminated &lt;a href=&quot;http://www.medpagetoday.com/MeetingCoverage/SCCM/5096&quot; mce_href=&quot;http://www.medpagetoday.com/MeetingCoverage/SCCM/5096&quot; target=&quot;_blank&quot;&gt;European Glucontrol Trial&lt;/a&gt; found no mortality benefit but a seven-fold higher risk of hypoglycemia with an 80 to 110 mg/dL target in the ICU.&lt;/p&gt;
&lt;p&gt;In the &lt;a href=&quot;http://www.medpagetoday.com/CriticalCare/Intensivists/13397&quot; mce_href=&quot;http://www.medpagetoday.com/CriticalCare/Intensivists/13397&quot; target=&quot;_blank&quot;&gt;NICE-SUGAR&lt;/a&gt; study, 90-day mortality was actually higher in the tight glucose control group (27.9% versus 24.9%, &lt;em&gt;P&lt;/em&gt;=0.02), although there was a trend for benefit in patients who got corticosteroids (&lt;em&gt;P&lt;/em&gt;=0.06).&lt;/p&gt;
&lt;p&gt;Glucose targets are being re-evaluated across medicine as the &quot;lower is better&quot; paradigm has had a safety asterisk added everywhere from diabetes care to the ICU, noted Richard Bergenstal, MD, American Diabetes Association president for medicine and science.&lt;/p&gt;
&lt;p&gt;&quot;All of a sudden it&apos;s becoming more than a single number,&quot; he told &lt;em&gt;MedPage Today&lt;/em&gt;. &quot;Now be it inpatient or outpatient, we&apos;re realizing that ... you have to do it while you&apos;re minimizing hypoglycemia.&quot;&lt;/p&gt;
&lt;p&gt;A more nuanced and &lt;a href=&quot;http://www.medpagetoday.com/Cardiology/Diabetes/13818&quot; mce_href=&quot;http://www.medpagetoday.com/Cardiology/Diabetes/13818&quot; target=&quot;_blank&quot;&gt;individualized&lt;/a&gt; strategy is prudent, Bergenstal agreed.&lt;/p&gt;
&lt;p&gt;The current clinical uncertainty underscores the need for large-scale international cooperation to get adequately powered trials, according to an accompanying editorial.&lt;/p&gt;
&lt;p&gt;In it, Greet Van den Berghe, MD, PhD, of the Catholic University of Leuven, Belgium, cautioned that Annane&apos;s Corticosteroids and Intensive Insulin Therapy for Septic Shock (COIITSS) study was grossly underpowered.&lt;/p&gt;
&lt;p&gt;The initial studies that led to rapid adoption of intensive insulin therapy in ICUs around the world had suggested an absolute reduction in mortality of only 3%, whereas the COIITSS study projected a 12.5% absolute benefit.&lt;/p&gt;
&lt;p&gt;More importantly, the study achieved mean glucose levels of only between 120 and 130 mg/dL in the intervention group for whom the aim was 80 to 110 mg/dL, which resulted in considerable overlap with the standard care group for whom mean levels were about 145 mg/dL.&lt;/p&gt;
&lt;p&gt;This could account for the lack of difference in outcome, Van den Berghe said.&lt;/p&gt;
&lt;p&gt;But the intensive insulin group did have &quot;markedly&quot; lower blood glucose levels for the duration of their ICU stay and spent more time in the 80 to 110 mg/dL range compared with the standard care group (both &lt;em&gt;P&lt;/em&gt;&amp;lt;0.00001), the researchers noted.&lt;/p&gt;
&lt;p&gt;Because corticosteroids further aggravate the &quot;diabetes of injury&quot; seen with septic shock, Annane&apos;s group undertook a multicenter trial of 509 adults treated for septic shock with multiple organ dysfunction over a three year period at 11 ICUs in France.&lt;/p&gt;
&lt;p&gt;Patients were randomly assigned to tight glucose control using continuous intravenous insulin infusion to target a glucose level of 80 to 110 mg/dL or conventional insulin therapy targeted to guidelines-recommended 150 mg/dL or under. They were additionally randomized to receive hydrocortisone alone (50-mg bolus every six hours) or in combination with fludrocortisone (50-&amp;#956;g tablets once daily) for seven days.&lt;/p&gt;
&lt;p&gt;Aside from the lack of inhospital mortality advantage, tight glucose control also failed to produce a benefit for the following secondary endpoints: &lt;ul&gt; &lt;li&gt;Overall survival (hazard ratio 1.04, &lt;em&gt;P&lt;/em&gt;=0.78) &lt;/li&gt; &lt;li&gt; ICU length of stay for survivors (median 10 versus nine days, &lt;em&gt;P&lt;/em&gt;=0.68)&lt;/li&gt; &lt;li&gt;Duration of hospital stay overall (24 versus 22 days, &lt;em&gt;P&lt;/em&gt;=0.87)&lt;/li&gt; &lt;li&gt;Median vasopressor-free days (four for both, P=0.58)&lt;/li&gt; &lt;li&gt;Median mechanical ventilation-free days (10 versus 13, &lt;em&gt;P&lt;/em&gt;=0.51)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Nor was there evidence for interaction with fludrocortisone in the primary endpoint (relative risk 0.89 versus 0.91 hydrocortisone alone, &lt;em&gt;P&lt;/em&gt;=0.31) or benefit in any other endpoint.&lt;/p&gt;
&lt;p&gt;The one effect of intensive insulin appeared to be an increase in episodes of severe hypoglycemia, defined by glucose falling below 40 mg/dL (mean 0.29 versus 0.14 episodes per patient, &lt;em&gt;P&lt;/em&gt;=0.003).&lt;/p&gt;
&lt;p&gt;However, having hypoglycemia did not increase the risk of death in intervention group patients compared with controls (45.2% versus 50%).&lt;/p&gt;
&lt;p&gt;The researchers cautioned that the study did not rule out a benefit from some degree of glucose control compared with none.&lt;/p&gt;
&lt;p&gt;They also noted that healthcare providers were not blinded to administration of fludrocortisone, for which no placebo was available.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was funded by the Assistance Publique&amp;#8211;H&amp;#244;pitaux de Paris. The researchers reported no conflicts of interest.&lt;/p&gt;&lt;p&gt;Van den Berghe, through the Catholic University of Leuven, reported receiving structural research financing from the Methusalem program, funded by the Flemish government.&lt;/p&gt;&lt;p&gt;Bergenstal reported receiving research funding and serving on advisory boards for various pharmaceutical companies related to novel diabetes drugs but without any personal financial compensation.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
</recommendedContent>
