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GLG News by Neonatal-Perinatal Physicians (US)

Analysis of: FDA Approves ROTARIX(R) Rotavirus Vaccine (www.pipelinereview.com)
Yes, rotavirus disease is common, but overall, it is low on the worry scale for pediatricians in the US. Adoption of the Rotateq (Merck) product has been relatively slow, and I do not expect anything more for Rotarix.
Analysis of: FDA Clears Glaxo Diarrhea - Virus Vaccine (www.nytimes.com)
-Glaxo's Rotarix vaccine was approved last week for prevention of rotavirus infection in infants -Merck's product, Rotateq, on the market for 2 years in the US, already has an established pipeline to essentially all pediatric primary care providers -There are small differences between the 2 vaccines,...
Analysis of: Molecular Testing for Respiratory Viruses (www.aacc.org)
While it is often "nice" to know specifically what virus might be causing symptoms, this knowledge generally has little effect on patient treatment. It might have a public health benefit, in terms of reducing contacts and spread, but this benefit is not generally considered to be cost-efficient (the...
Analysis of: Molecular Testing for Respiratory Viruses (www.aacc.org)
While it is often "nice" to know specifically what virus might be causing symptoms, this knowledge generally has little effect on patient treatment. It might have a public health benefit, in terms of reducing contacts and spread, but this benefit is not generally considered to be cost-efficient (the...
Analysis of: FDA Investigating Possible Link Between Singulair and Suicide (www.foxnews.com)
Post marketing studies, required by the FDA, are the lowest form of study. There is no blinding of the investigator, no control group and no ability to quantify risk vs. benefit. There is also no denominator to the numerator of alleged side effects reported, so true risk cannot be assessed.
Analysis of: The Outlook on Home, Direct Access Testing (www.aacc.org)
Sometimes I wonder what I got out of all the years I spent in training?
March 31, 2008
So it begins...
Analysis of: FDA Investigating Possible Link Between Singulair and Suicide (www.foxnews.com)
-Reports of suicidality have been added to Mercks' PI for Singulair -The media have begun to report on this in the past few days and patients are already making calls to their docs -A la Vioxx, Singulair is poised to become the next whipping boy for every depressed asthmatic...
Analysis of: Vaccinating Boys for Girls’ Sake? (www.nytimes.com)
Everyone who thinks that the FDA is going to license a vaccine as costly as Gardasil for boys is insane (sorry if I'm being too subtle). Girls get cervical cancer; the rates of penile and anal cancers from HPV is minuscule in comparison. The cost of Gardasil for girls alone is going to strain a...
Analysis of: Health insurers take a dive on WellPoint's warning (www.marketwatch.com)
Face the facts: In the US, health care costs are, in large part, demand driven. Sure, there is the supply push issue, but very few physicians actually would subject their patients to unnecessary services or procedures--and those who do continue to face censure and exclusion from insurance plans and...
Analysis of: Phase II Clinical Trial of ALN-RSV01 Demonstrates Statistically Significant Anti-Viral Efficacy with an Approximately 40% Reduction in RSV Infection Rate and 95% Increase in Infection-Free Subjects (www.pipelinereview.com)
This is a very interesting concept, especially since RSV, a major cause of illness in very young children, has been difficult to both prevent and treat. Should the process described here pan out, it opens the door to the development of clinical applications.

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