Pediatric CVD Report Slights Nutrition’s Role, Weighs On OTC Statin Chances

An American Academy of Pediatrics report recommending prescribing statin drugs for cardiovascular disease in children could present another roadblock for switching statins to OTC.

The report also is stirring concern in the medical and natural health communities that a trend toward prescribing statins for children could replace non-pharmaceutical measures such as diet and exercise.

With concern emerging about the safety of wider access to the drugs - including overdose risks and use by children who do not fit the recommended patient profile - the report could make FDA even less inclined to approve Rx-to-OTC switches of the drugs.

FDA has already denied three switch applications for Merck's Mevacor Daily (lovastatin 20 mg) following advisory committees' recommendations against the switch ('The Tan Sheet' Jan. 28, 2008, In Brief).

When FDA's Nonprescription Drugs and Endocrinologic and Metabolic Drugs advisory committees recommended against the latest Mevacor Daily switch application in December 2007, they said there was a lack of "real world" experience on how consumers make OTC selections ( (Also see "FDA Advisors Say Greater Insight Needed On Self-Selection Of OTC Statins" - Pink Sheet, 17 Dec, 2007.), p. 3).

Loren Israelsen, executive director of the United Natural Products Alliance, expects the AAP report will lead some parents to look for quick fixes for children's health problems. OTC access to statins would only accelerate that practice.

Israelsen notes that while the AAP report mentions the importance of diet and nutrition, "the fact is, if there is an easy pill for parents to give kids, many of them will," he said.

He added that the "'diseasification' of youngsters is unsustainable." As an example, he referred to Efficacy Brands' marketing of Obecalp , a sugar pill marketed as a supplement for young children ( (Also see "Placebo Causes Adverse Reaction With Industry, Raises Regulatory Concerns" - Pink Sheet, 2 Jun, 2008.), p. 9).

Israelsen believes the AAP report is another example of "therapeutic creep," moving treatment recommendations beyond boundary lines to increase the scope of potential users.

"I would hope FDA would be extraordinarily conservative before granting a pediatric indication for statins," he said. "I would also hope pediatricians would not be unduly influenced to write a scrip for a pill when they should be telling parents to exercise with their kids, turn off the TV and Gameboys [and] break out the veggies."

Hugo Rodier, a physician and medical director of Pioneer Clinic, an integrative health center in Draper, Utah, said he believes pediatricians would initially resist prescribing statins to children.

However, over time physicians are "likely to lose their inhibitions and prescribe them too often, without trying to change the kids' diets," Rider said.

He criticizes AAP's recommendation on statins because it gives a pharmaceutical answer to nutritional problems, a "paradigm that will perpetuate health problems, rather than solve them," he added.

AAP Responds To Childhood Obesity Epidemic

Authored by researchers led by Stephen R. Daniels, Department of Pediatrics chairman at the University of Colorado School of Medicine, the report recommends that, among other approaches, physicians consider prescribing statins to children 8 years old and up who have concentrations of low-density lipoprotein cholesterol equal to or greater than 190 mg/dL.

The authors cite existing safety data and FDA's approval of pravastatin for children who are at least 8 years old and have familial hypercholesterolemia.

Posted on the academy's Web site, the report was drafted in response to an urgency raised by the epidemic of childhood obesity and replaces the 1998 policy statement from the AAP on cholesterol in childhood.

The report also urges doctors to screen at-risk children and encourage parents to follow dietary guidelines and increase children's physical activity.

- Eileen Francis ([email protected])