Cholesterol Debate Rages On

Hot topic of the day: “Pediatricians React to New Cholesterol Rules” by Tara Parker-Pope (NYT “Well” blog author). Count me in.

From the NYT print and online editions:

“To be frank, I’m embarrassed for the A.A.P. today,” said Dr. Lawrence Rosen of Hackensack University Medical Center in New Jersey, vice chairman of an academy panel on traditional and alternative medicine. He added: “Treatment with medications in the absence of any clear data? I hope they’re ready for the public backlash.”

No, I was not misquoted, though it’s a bit strong on second read. I was NOT however representing HUMC, which I made clear to the NYT; I was stating my opinion as an individual pediatrician and as a concerned member of the AAP. In fact, I have a leadership role within the Academy, serving as Vice-Chair of the Section on Complementary and Integrative Medicine. I have been an AAP Fellow since residency, though at times (like this one) I am not particularly proud to admit it. I continue to believe, though, that AAP at its best has the potential to advocate for children unlike any other organization on the earth. The AAP was founded on the principle that children needed a voice, too – that they are not just little adults and that their health and wellness is crucial to the success of our country. The group has been instrumental in leading the charge to make sure medications and devices are tested for efficacy and safety specifically in children so that we don’t assume these therapies are safe based on adult research only. Which is why it’s so maddening when policies like this new cholesterol one miss the mark so widely.

“We extrapolate from the information we have in adults,” said a member of the panel, Dr. Nicolas Stettler, an assistant professor of pediatric epidemiology at the Children’s Hospital of Philadelphia. “We know that in adults, decreasing cholesterol and giving some of those drugs decreases risk of heart disease or death. So there’s really no reason to think that would be any different in children.”

I strongly disagree. There are SO many reasons to think this would be different in children. The “this” in this case are statin drugs – the billion dollar cash cow for pharmaceutical companies like Pfizer (Lipitor) and Merck (Mevacor). There is debate even in adult medicine circles about how effective or safe these medicines are. There is even uncertainty, especially in children, about how crucial lipid measurements are with respect to cardiovascular disease. Do the benefits of treating even high-risk children with statin meds from the age 8 until 88 outweigh the risks? Honestly, the one thing there is consensus about is that WE DON’T KNOW. We’re not even sure who and when to screen.

I do know this:

1. Big pharma is worried about profit loss as statin meds go generic.

2. The AAP sign-off on using statins for kids will support applications to the FDA for approval in a brand new market.

3. New market = new indication = profits for big pharma.

From the Times article:

“It will open the door for pharmaceutical companies to heavily advertise and promote their use in 8-year-olds, when we don’t know yet the long-term effect on using these drugs on prepubertal kids,” said Dr. Alan Greene, a pediatrician in Danville, Calif., and the founder of the popular Web site DrGreene.com.

Is the whole AAP policy about drugs? No, very little is. It is mostly a worthwhile read about trends in lipid disorders in children (questionably epidemic – lipid levels in kids are acknowledged to be flat over a fairly long time, though obesity and metabolic syndrome are one the rise). There is a (way too minimal for my taste) discussion about lifestyle prevention and treatment – nutrition and fitness (and nary a mention of psychological aspects of eating). We can quibble over the dated food pyramid approach to nutrition (i.e. why is cow’s milk necessarily the gauge for what passes for nutritious?). But the bigger issue is this – including an endorsement for medication treatment of a lab test abnormality leaves the AAP open to a huge public backlash and criticism on conflict-of-interest charges.

Dr. Peter Rost, aka “The Whistleblower“:

“Why, then, does the American Academy of Pediatrics recommend a dubious course of treatment with drugs instead? One clue may be found in list of donors who include McDonald-whose fast-food has contributed mightily to US children’s obesity and cholesterolepidemic-and pharmaceutical companies that market statins, such as, AstraZeneca (Crestor), Sanofi-Aventis (Zocor), Merck (Mevacor, Vytorin) (http://www.aap.org/donate/fcfhonorroll.htm).”

It just doesn’t look right when, as Parker-Pope notes, “None of the doctors on the academy’s nutrition panel have disclosed any financial relationship with makers of statin drugs. (The report’s lead author, Dr. Stephen Daniels, told The Associated Press that he had worked as a consultant to Abbott Laboratories and Merck, but not on their cholesterol drugs. He was not available for comment on Monday.)” Criticism of the AAP regarding pharma sponsorship is not new. I wrote about the “good, bad and ugly” last fall after speaking at the NCE. There is a disturbing trend in practice I’ve noted over the past year. I find that families are so skeptical right now about the AAP – whether it be about vaccines or other pharmaceuticals – and this latest foray just makes them look out of touch, at best. For the AAP to reclaim its mantle as the nation’s premier voice for promoting children’s health and wellness, we must be willing to hear the voices (yes, even the angry ones – and there are many) of families across the land. At no time in our history is this more crucial than right now. It will only be through listening to children, parents and concerned member pediatricians that this can happen, though. I, for one, believe we can, if we work together.