Consider The Evidence: Med/Peds Journal Roundup

September 11, 2009

the (new) Gardasil controversy

Filed under: immunity, JAMA, pediatrics, vaccines — medblog @ 3:19 pm

JAMA 8/19/09 – In case the Gardasil vaccine wasn’t already surrounded by enough controversy – now there is concern over its safety profile and the marketing practices of Merk. An article in JAMA presents the safety surveillance data for qHPV, finding that “Most of the AEFI rates were not greater than the background rates compared with other vaccines, but there was disproportional reporting of syncope and venous thromboembolic events”

An accompanying editorial discusses the extensive marketing to and through medical professional organizations via the use of manufacturer – designed educational matierials (i.e. brochures, posters, etc)

Some of the adverse event rates can sound pretty scary, especially the 32 reports of death and the elevated rates of VTE. But there are big  problems with the use of VAERS data to assess risk because the reporting comes from a variety of sources, with differing levels of detail and its hard to take away any understanding of causation at all. For example 90% of the patients with VTE had at least one other risk factor. It would be great to rely solely on the controlled safety trial data but they will never have the raw numbers to catch rare events that is found with broad observational data.

The other issue with Gardasil is that there are still many unanswered questions about efficacy. It is unclear what impact this will truly have on cervical cancer rates for many reasons. First, the duration of immunity is unclear. Second, there are several oncogenic strains of HPV that are not covered in the vaccine. And third, proper routine screening is readily available and significantly decreases the risk of developing cervical cancer. Just the fact that screening still has to be done regardless of vaccination status is going to make patients wonder about the point of even getting the vaccine.

All of this seems to add up to many potentially difficult conversations with parents to try to address in the context of a 15-minute office visit – but I’m pretty used to running behind at this point….

July 30, 2006

Yes to NO for preemies?

Filed under: NEJM, pediatrics, pulmonary — medblog @ 8:14 pm

NEJM 6/27 – Two articles address the controversial use of inhaled Nitric Oxide in pre-term infants. Prior studies have shown that nitric-oxide may improve gas exchange and lung development in neonates with respiratory failure. Ballard et al. tested this hypothesis on infants weighing less than 1250g, while Kinsella et al. studied all infants less than 34 weeks of age with respiratory failure.

While Ballard et al. found a significant reduction in the incidence of bronchopulmonary dysplasia, the effect size was not large (43.9 vs 36.8) and the P value made it just under the wire at 0.042.

Kinsella et al. found no difference in mortality for the overall group, but did find a significant improvement in outcomes for the group weighing between 1000-1250g, as well as improvement in several secondary outcomes.

Clearly there has to be some futher research into what patients will benefit most from this expensive therapy before it becomes standard of care. 

NEJM Vol. 355(4)

March 12, 2006

Soft drinks and pediatric obesity

Filed under: diet, health, pediatrics — medblog @ 10:47 am

Pediatrics 3/06 – Is the availability of sugary sodas contributing to the epidemic of pediatric obesity?
There is plenty of observational data on the subject, but not very many RCTs. An article in the most recent issue of Pediatrics lends some evidence to the argument. Ebbeling et al. investigated whether offering sugar-free beverages changes the diet patterns of children, and whether this leads to a corresponding weight loss. In the study, adolescents in the intervention group were randomly assigned to receive sugar-free beverages delivered to their home.

Among the children who recieved sugar free beverages, the drop in BMI was only significant in those children with a BMI > 30. Children in the intervention group actually lost some weight, while the control subjects gained weight. The results were not incredibly dramatic as the overall effect was less than 1 kg/m^2. However, it is impressive that such a change was caused by just one simple dietary intervention. (more…)

February 2, 2006

Choosing which kids with head injury get CT – NEXUSII

Filed under: pediatrics — medblog @ 4:17 am

Pediatrics 2/1 – Its often hard to decide which kids with head trauma can go home without a head scan. As part of the NEXUSII trial, Oman et al. investigate which criteria best predict intracranial injuries (ICI) in kids that bonk their heads. Using some fancy analysis they found the 7 best criteria from a set of 19 that identify those at highest risk for ICI. This decision rule had 98.6% sensitivity (missed only 2 of 1666 pts with ICI) and correctly worked in all cases of patients under 3 y/o who are often more difficult to assess . (more…)

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