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GLG News by this Author
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More Progress on the Vaccine Front
June 6, 2008
Novartis presents full pipeline of novel vaccines addressing significant unmet needs | www.pipelinereview.com
Novartis is developing vaccines for diseases for which there are no current products available. Group B Strep, N. meningitidis Group B and H. Pylori are all common pathogens and cause significant morbidity.
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Good Summary of Current Practices
May 20, 2008
Guidelines Issued for Treating Atopic Eczema in Children | www.medscape.com
This article summarizes in a concise format what most of us do anyway. Nonetheless, it is good to have the steps clearly spelled out.
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May 19, 2008
Analyst: $850M opportunity for Allscripts with merger | www.forbes.com
I'd go with the second analyst in the article, who points out the exosting product overlap between the two companies.
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May 19, 2008
Renal Failure Linked to Cosmetic Soft-Tissue Filler Injections | www.medscape.com
The major effect, I would hope, would be to keep people from using unlicensed practitioners to do unapproved procedures with inappropriate products.
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Will Not Meaningfully Change Prescribing Patterns
May 12, 2008
FDA Approves Strattera® for Maintenance of ADHD in Children and Adolescents | newsroom.lilly.com
While this is new data from an 18 month study, the common practice already is to "stick with what works." Thus, if a child is started on Strattera (or another ADHD medication) and has positive results, the physician will most likely continue that drug.
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A New Non-stimulant Approach to ADHD?
May 12, 2008
Abbott Scientists Present A New Approach for Treating Attention-Deficit Hyperactivity Disorder | biz.yahoo.com
Although just a press release, the itself study is interesting. The attempt to modify the symptoms of ADHD by affecting neurotransmitter release or reuptake is not new, but this is an attempt to do so via a novel receptor pathway.
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Not the Utility One Might Expect
May 8, 2008
Physician report card validity | physiciansnews.com
Physician ranking systems will certainly be a part of medical practice. But the real utility is not going to be in allowing patients to choose the "best" doctors--that will perpetuate the fallacy of drawing conclusions about a specific case from the general data. And the ability of this information to save money for insurance companies is yet to be proven.
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May 7, 2008
Novartis Menveo® vaccine shows superior immune response against four types of meningitis disease in pivotal phase III trial | www.novartis.com
Menveo appears to have some statistical advantages over the currently available product, Menactra (sanofi aventis.) Whether the higher antibody levels translate into better or more lasting protection remains to be seen. Given recent FDA action approving meningococcal vaccine for younger pediatric age groups, if Menveo is approved for infants, I would expect that it would gain a large market share, since most physicians would rather stock a single product, and would opt for the one with the broadest utility.
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April 14, 2008
Federal Court Sides With GlaxoSmithKline, Strikes Down Rules Issued by Patent Office | biz.yahoo.com
The proposed PTO rules, while logical on the surface, suffer from the all too common defect of over-generalization. In patent applications, as in so many other fields, there is usually not a one size fits all approach.
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Not a Huge Advantage Over the Current Product
April 9, 2008
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.
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Limited Clinical Utility Doesn't Necessarily Stop a Test from Being Used
April 4, 2008
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 gold standard today!)
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Limited Clinical Utility Doesn't Necessarily Stop a Test from Being Used
April 4, 2008
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 gold standard today!)
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Cause and effect? Or just temporal association?
April 1, 2008
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.
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First OTC Diagnostic Testing, then Home-based Auto-surgery?
April 1, 2008
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?
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Health Plans Cannot Control Costs Any More Than Physicians Can
March 19, 2008
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 Medicare.
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March 7, 2008
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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March 6, 2008
FDA Approves Nexium for Use in Children Ages 1-11 Years | pharmalive.com
As is the case with choice of PPI's in adult patients, in pediatrics we now have a large number of effective drugs from which to choose. However, "managed care" policies limit the choices and make the prescribing of newer products problematic.
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"I am Not a Doctor but I Play One on TV...."
March 6, 2008
Drug Pitchmen: Actor, Doctor or Pfizer’s Option | www.nytimes.com
Why is the Jarvik ad campaign any more offensive than the famous line quoted above? If any direct-to-consumer (DTC) advertising is acceptable, then why is there any furor over the use of actors who are not technically qualified as pitchmen?
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March 6, 2008
Your Hospital's Deadly Secret | www.portfolio.com
As hospitals outsource everything, from laboratory management to emergency rooms to pharmacies, control of these areas is being lost, often to the detriment of patients.
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Newer and More Effective Adjuvants are a Start
March 6, 2008
Intercell completes Phase I clinical trial for improved seasonal Flu vaccine formulated with IC31(R) | www.pipelinereview.com
While new adjuvants always hold promise, and Intercell's product seems to be efficacious without undue reactogenicity, any vaccine is only as good as its raw materials. This year's flu vaccine's lack of efficacy is a case in point.
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