<?xml version="1.0" encoding="utf-8"?>
<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_437"
                     title="Autism Risk Linked to Maternal Age (CME/CE)"
                     score="0.014"
                     href="http://www.medpagetoday.com/Pediatrics/Autism/tb/18341?impressionId=1265811905104"
                     
      Older women are more likely to give birth to a child who develops autism than younger women, but the father&apos;s age is a factor only when moms are younger, a large case-control study showed.&lt;br&gt;
&lt;br&gt;In an analysis of nearly five million births and more than 12,000 autism cases, every five-year increase in maternal age at delivery was associated with an 18% greater risk of the child later being diagnosed with autism, according to Janie Shelton, MPH, a doctoral student at the University of California Davis, and colleagues.&lt;br&gt;
&lt;br&gt;Mothers who gave birth when they were 40 or older had a 51% increased risk of having a child with autism compared with those who were 25 to 29, the largest age group (OR 1.51, 95% CI 1.35 to 1.70), the researchers reported in the February issue of &lt;em&gt;Autism Research&lt;/em&gt;.&lt;br&gt;
&lt;br&gt;The effect of the biological father&apos;s age appeared to depend on the mother&apos;s. When the mothers were 30 and older, paternal age did not significantly increase the risk of having a child develop autism. In mothers younger than 30, paternal age did contribute to the autism risk.&lt;p&gt;&lt;/p&gt;
&lt;p&gt;&quot;This study builds upon earlier work that has demonstrated associations between parental age and autism risk,&quot; commented Bryan King, MD, program director of the Seattle Children&apos;s Autism Center, in an e-mail.&lt;/p&gt;
&lt;p&gt;But previous studies have yielded mixed results on the relative contributions of the mothers&apos; and fathers&apos; ages.&lt;/p&gt;
&lt;p&gt;&quot;I think the size of the sample used in the present study (close to five million births) has resulted in a clear signal that both maternal and paternal age are involved,&quot; said King, who was not involved in the study.&lt;/p&gt;
&lt;p&gt;He noted, however, that parental age &quot;does not account for the big increase in autism prevalence, although it may be contributing somewhat.&quot;&lt;/p&gt;
&lt;p&gt;Shelton and her colleagues calculated that the rising average maternal age during their study  --  covering 1990 to 1999  --  contributed to a 4.6% increase in autism incidence. That compares with about a six-fold increase in autism rates in that decade, Shelton said in an interview.&lt;/p&gt;
&lt;p&gt;&quot;I worry a little bit that in the media attention on this issue that mothers who had children at ages 37, 38, 39 might think that, &apos;Okay, well that&apos;s why my child had autism,&apos;&quot; she said. &quot;And so, I think it&apos;s important to stress that the increased number of cases that we&apos;ve observed can&apos;t be attributable towards women having children later.&quot;&lt;/p&gt;
&lt;p&gt;The researchers looked at data from 4,935,776 singleton births in California in the 1990&apos;s using records from the state Department of Development Services. Records identified 12,159 cases of &quot;Full Syndrome Autism&quot; diagnosed before age 6.&lt;/p&gt;
&lt;p&gt;That diagnosis may include autistic disorder, as well as Asperger&apos;s disorder and pervasive developmental disorder not otherwise specified. However, the breakdown of specific diagnoses could not be determined from this data set, Shelton said.&lt;/p&gt;
&lt;p&gt;Even after controlling for parental education, the year of the child&apos;s birth, the race/ethnicity of the parents, the mother&apos;s parity, and insurance payment type, older maternal age was associated with an increased risk of autism in the child.&lt;/p&gt;
&lt;p&gt;Nancy Minshew, MD, director of the Center of Excellence in Autism Research at the University of Pittsburgh, said in an e-mail that the results were not surprising because genetic errors are more common with older parents.&lt;/p&gt;
&lt;p&gt;King said genetics were one possible mechanism underlying the relationship.&lt;/p&gt;
&lt;p&gt;&quot;The mechanisms by which risk goes up might include a greater likelihood of chromosomal changes, a greater likelihood of problems at birth like prematurity, and many other factors,&quot; he said. &quot;The possibility of environmental exposures would also be expected to increase with age, and so this finding does not necessarily help narrow our focus on causes.&quot;&lt;/p&gt;
&lt;p&gt;Sheldon and her colleagues wrote, &quot;It is plausible that multiple exposure types may increase the risk of autism through a common pathway or pathways (i.e., mitochondrial function, thyroid function, epigenetics, hormonal alterations) and be represented as a generalized increased risk with age.&quot;&lt;/p&gt;
&lt;p&gt;&quot;In this case,&quot; they continued, &quot;maternal or paternal age would serve as an index of lifetime exposure status and be a proxy for the true underlying etiologic agent.&quot;&lt;/p&gt;
&lt;p&gt;Shelton said further research is needed to determine why biological age is serving as a risk factor for autism.&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 grants from the National Institute of Environmental Health Sciences and the Environmental Protection Agency and by the University of California Davis School of Medicine and Office of Graduate Studies.&lt;/p&gt;&lt;p&gt;The researchers did not report any conflicts of interest.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&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_368"
                     title="Lancet Retracts 1998 MMR-Autism Paper"
                     score="0.011"
                     href="http://www.medpagetoday.com/Pediatrics/Vaccines/tb/18255?impressionId=1265811905104"
                     
      &lt;p&gt;Editors of &lt;em&gt;The Lancet&lt;/em&gt; have retracted the 1998 study that first suggested autism might be caused by the MMR vaccine, less than a week after an official rebuke to the paper&apos;s lead author, Andrew Wakefield, MBBS, and two co-authors.&lt;/p&gt;
&lt;p&gt;In a brief note posted on the journal&apos;s Web site, &lt;em&gt;Lancet&lt;/em&gt; editors wrote, &quot;It has become clear that several elements of the 1998 paper by Wakefield et al. are incorrect, contrary to the findings of an earlier investigation.... Therefore, we fully retract this paper from the published record.&quot;&lt;/p&gt;
&lt;p&gt;Evidence presented in a Jan. 28 hearing before the U.K. General Medical Council&apos;s Fitness to Practise Panel persuaded the journal that the paper had misrepresented how the study was conducted.&lt;/p&gt;
&lt;p&gt;&lt;span class=&quot;msgBody&quot;&gt;The council, which has no direct American equivalent, is an independent, nationwide regulatory body that registers doctors and enforces standards of medical practice in the U.K.&lt;/span&gt;&lt;/p&gt;
&lt;p&gt;Hospital records and other sources contradicted findings of a 2004 investigation by Wakefield&apos;s institution, the Royal Free and University College, that the study had been properly vetted by an institutional review board.&lt;/p&gt;
&lt;p&gt;&quot;The claims in the original paper that children were &apos;consecutively referred&apos; and that investigations were &apos;approved&apos; by the local ethics committee have been proven to be false,&quot; according to the &lt;em&gt;Lancet&lt;/em&gt; editors.&lt;/p&gt;
&lt;p&gt;The editor of Britain&apos;s other leading medical journal, &lt;em&gt;BMJ&lt;/em&gt;, congratulated &lt;em&gt;The Lancet&lt;/em&gt; for its action.&lt;/p&gt;
&lt;p&gt;&quot;This will help to restore faith in this globally important vaccine and in the integrity of the scientific literature,&quot; according to a statement from Fiona Godlee, MB, BChir, BSc.&lt;/p&gt;
&lt;p&gt;In the 1998 paper, Wakefield and colleagues reported on findings in 12 children who, they said, had developed intestinal inflammation and autistic symptoms following MMR vaccination. They suggested that the inflammation released gut proteins into the circulation that eventually migrated to the brain, causing permanent damage reflected in autism symptoms.&lt;/p&gt;
&lt;p&gt;The report and the ensuing mass-media publicity sparked consternation among parents and the medical community. Vaccination rates in Britain and the U.S. dropped sharply, and measles rates spiked in consequence.&lt;/p&gt;
&lt;p&gt;Although subsequent population-based research and other studies have failed to confirm a causal link between MMR vaccines and autism, a vocal group of parents of autistic children continues to insist that it is real. They call Wakefield a hero.&lt;/p&gt;
&lt;p&gt;However, a nearly decade-long investigation by a British journalist, Brian Deer, uncovered discrepancies between the &lt;em&gt;Lancet&lt;/em&gt; paper and hospital records and other sources. (See &lt;a href=&quot;http://www.medpagetoday.com/Pediatrics/Autism/12850&quot; mce_href=&quot;http://www.medpagetoday.com/Pediatrics/Autism/12850&quot; target=&quot;_blank&quot;&gt;Father of Vaccine-Autism Link Said to Have Fudged Data&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;Whereas the &lt;em&gt;Lancet&lt;/em&gt; paper indicated that, in most cases, symptoms developed within days of vaccination, the records indicated that this was true only for one child, according to Deer&apos;s account in the &lt;em&gt;Times of London&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;The patients&apos; records also indicated that five of the children had psychosocial problems before vaccination, said the &lt;em&gt;Times&lt;/em&gt;, but the &lt;em&gt;Lancet&lt;/em&gt; paper described them as &quot;developmentally normal.&quot;&lt;/p&gt;
&lt;p&gt;In addition, the &lt;em&gt;Lancet&lt;/em&gt; paper described abnormal intestinal pathology results in the children, but the hospital pathology reports showed no findings of inflammation, the &lt;em&gt;Times&lt;/em&gt; report said.&lt;/p&gt;
&lt;p&gt;At last week&apos;s hearing, the U.K.&apos;s General Medical Council panel heard evidence that Wakefield had taken blood samples from children attending his son&apos;s birthday party and performed spinal taps on other children in a hospital without due regard for their safety.&lt;/p&gt;
&lt;p&gt;The panel found Wakefield guilty of more than 30 charges that he had acted unethically in conducting the study. He could be stripped of his license to practice in Britain, but no ruling has been made yet.&lt;/p&gt;
&lt;p&gt;Two of Wakefield&apos;s 12 co-authors on the 1998 paper, John Walker-Smith, MD, and Simon Murch, PhD, were also found to have committed ethical violations. The other 10 co-authors had previously repudiated the paper&apos;s findings and were not charged.&lt;/p&gt;
&lt;p&gt;Wakefield was in London while the hearing took place but did not attend. Afterward, he told reporters he was innocent of wrongdoing and would continue his research.&lt;/p&gt;
&lt;p&gt;Wakefield is now based at Thoughtful House, a private autism research and treatment facility in Austin, Texas. After the panel&apos;s ruling, it issued a statement expressing disappointment and calling the charges &quot;unfounded and unfair.&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=1265811905104"
                     
      &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_296"
                     title="FDA Okays Morphine for Tolerant Patients"
                     score="0.005"
                     href="http://www.medpagetoday.com/PainManagement/PainManagement/tb/18157?impressionId=1265811905104"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has approved the first high-concentration, oral morphine sulfate solution as part of its unapproved drugs initiative.&lt;/p&gt;
&lt;p&gt;The drug is indicated for opioid-tolerant patients with moderate-to-severe acute and chronic pain, as well as end-of-life care.&lt;/p&gt;
&lt;p&gt;Opioid tolerance was defined as a patient using 60 mg of an opioid per day, Sharon Hertz, MD, deputy director of the Division of Anesthesia, Analgesics, and Rheumatoid Products at the Center for Drug Evaluation and Research, said in a conference call.&lt;/p&gt;
&lt;p&gt;The new solution is available in 100 mg per 5 mL and 20 mg per 1 mL concentrations.&lt;/p&gt;
&lt;p&gt;Although morphine use in pain management has been a common practice, this form and concentration of the drug was not previously FDA approved.&lt;/p&gt;
&lt;p&gt;Approval for the new drug was based on efficacy and safety data already available, which applicants can use when seeking approval for unapproved formulations of drugs with a known safety profile, Hertz said.&lt;/p&gt;
&lt;p&gt;The FDA initiated the unapproved drugs initiative in March, 2009, when it sent warning letters to nine companies requesting they pull a number of morphine sulfate, oxycodone, and hydromorphone products from the market. (See &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/13526&quot; mce_href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/13526&quot; target=&quot;_blank&quot;&gt;FDA Acts Against Unapproved Narcotic Drugs&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;Seven of the warned companies produced unapproved concentrated morphine sulfate, but the FDA granted a reprieve from the initiative when it could not find a suitable approved replacement for the drug without disrupting patient care. (See &lt;a href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/13682&quot; mce_href=&quot;http://www.medpagetoday.com/ProductAlert/Prescriptions/13682&quot; target=&quot;_blank&quot;&gt;FDA Gives Temporary Reprieve to Unapproved Morphine Elixir&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;The agency worked with manufacturer Roxane Laboratories to ensure that a sufficient supply of the drug was available and to develop a prescription and use guide for the medication.&lt;/p&gt;
&lt;p&gt;As part of the approval, the manufacturer needed to establish a safety profile prior to approval to address the risks of morphine misuse, abuse, and overdose.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_252"
                     title="MS Walking Drug Gets FDA Nod"
                     score="0.001"
                     href="http://www.medpagetoday.com/Neurology/MultipleSclerosis/tb/18112?impressionId=1265811905104"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has approved the first drug that improves walking in patients with multiple sclerosis, the tablet dalfampridine (Ampyra).&lt;/p&gt;
&lt;p&gt;The approval was based on clinical trial data that found patients could walk better with the drug than those treated with placebo.&lt;/p&gt;
&lt;p&gt;Patients who exceed recommended dosage, 10 mg twice a day, or who have moderate to severe kidney disease, may experience seizures the FDA said.&lt;/p&gt;
&lt;p&gt;Adverse events reported during clinical trials include urinary tract infection, insomnia, dizziness, headache, nausea, weakness, back pain, balance disorder, swelling of the nose or throat, constipation, diarrhea, indigestion, throat pain, and burning, tingling, or itching skin.&lt;/p&gt;
&lt;p&gt;The drug is manufactured by Elan of Dublin, Ireland and distributed by Acorda Therapeutics Inc. of Hawthone, NY.&lt;/p&gt;

    </recommendedItem>
</recommendedContent>