In July, the American Academy of Pediatrics (AAP) updated its guidelines for managing high cholesterol in children. The revisions generated a blizzard of media attention that surprised many in the pediatrics community.

After all, the revisions were for the most part incremental compared with previous iterations: slightly more comprehensive screening, an emphasis on the quality of fat intake rather than total fat intake, and a reduction in the recommended age for initiating drug therapy from 10 to 8 years.

There was one thing though, that was not incremental. The AAP now recommends statins as potential first-line cholesterol-lowering drugs for kids in whom efforts to lose weight and exercise fail to sufficiently reduce high cholesterol level. The older version made no mention of statins and recommended bile acid-binding drugs instead.

The bile acid binders don’t work well and are poorly tolerated. Statins work exceedingly well and are well tolerated in adults. The problem is that there is only limited, short-term data showing statins are safe in kids. In selecting a drug to recommend, the AAP had to trade-off unknown long-term risks of statins vs. their clear superiority as cholesterol lowering agents.

Sales of statins are already in the billions and how exactly can we subject our kids to unknown risks like that? The reasons for the firestorm are clear.

Now, two Harvard clinicians have posited that the epidemic of childhood obesity is the larger contextual issue at work here. That is what drives unprecedented numbers of kids to the point where they need cholesterol-lowering drugs in the first place. And that is what forces pediatricians to use other powerful “adult” drugs like diuretics and beta blockers for high blood pressure, insulin sensitizers for metabolic syndrome, and even aspirin for coagulopathies that these kids end up with in addition to high cholesterol. We don’t know much about how these drugs work in kids, either.

(more…)

Nearly 60% of the clinical trials that the FDA reviewed during its approval processes for new drugs between 1998 and 2000 were not published in peer reviewed journals within 5 years after the drugs went to market, according to research published in PLoS Medicine. 

24% of the non-published studies were “pivotal” trials focusing on safety and effectiveness in humans. Within this cohort, the PLoS study revealed publication bias: trials showing significant benefits for a new drug were more likely to be published than those showing no benefit.

Pharmaceutical companies sponsor the studies in question and they get to decide whether to pursue publication of trial results or squelch them.

PLoS study investigators concluded that Big Pharma’s failure to publish the results of all trials amounted to “scientific misconduct” that “harms the public good” because it prevents physicians from making informed decisions on behalf of their patients.

Things may be about to change at least a little however. The 2007 FDA Amendments Act mandated that substantial detail from all trials used in support an FDA approval process must be posted on the NIH clinical trials site. This is a good step, but maybe not enough. Clinicians may or may not recognize the unique value of the newly informed NIH site, much less use it. And it doesn’t address the problem with publication bias at all.

httpv://www.youtube.com/watch?v=NH1ujxNwrkA

Previous Worst Time Out in History

It’s yesterday morning. The Big O’s peeps call their Republican counterparts to suggest releasing a joint statement on the financial crisis. The Republicans agree. For six hours there’s no contact, and then look! It’s Top Gun on the tube! He’s suspending his campaign and stepping out to help solve the financial crisis.

Thank heavens! Washington needs his vast economic expertise right now.

McCain also says he wants to suspend Friday’s debate. A time out in the middle of a presidential campaign? Technical foul!

Here is how the Big O responded: “It is my belief that this is exactly the time when the American people need to hear from the person who, in approximately 40 days, will be responsible for dealing with this mess. It is going to be part of the president’s job to deal with more than one thing at once.”