Lipitor, Pfizer’s blockbuster cholesterol-lowering statin medication, has been approved for use in children with heterozygous familial hypercholesterolemia in the US since 2002, according to Pharmafile. (FH is an “inherited disorder that leads to aggressive and premature cardiovascular disease”). And those with FH are likely in great need of Lipitor.
But FH is a pretty rare disease. And Pfizer’s putting a lot of effort into chewable Lipitor.
Is Pfizer is positioning itself to profit – at the expense of children – by inducing pediatricians to more broadly prescribe Lipitor for children?
Perhaps. And that is very distressing.
Pfizer gained approval in the EU to market a grape-flavored, lower-dose, chewable form of Lipitor — in exchange for patent extension of regular Lipitor (read, short-term profit). Indeed, according to Andrew Jack of the Financial Times,
“Pfizer could earn $800m after European Union countries extended exclusive rights to sell its top-selling drug Lipitor until summer next year, in exchange for tests that will provide a slightly modified form of the medicine to just a few thousand children.”
So Pfizer used the EU’s controversial pediatric regulations, “which were introduced in 2007 with the offer of extended exclusivity as a financial incentive to encourage drug companies to ensure they expanded testing of experimental medicines to include children,” for short-term financial gain.
Typical big pharma move. Totally legal. Much debate about ethics.
More worrisome is what could come down the road.
For there is potential for Pfizer to use the same agressive marketing tactics they have employed to induce over-medication of adult Americans with high cholesterol and no other heart disease risk factors…now with KIDS.
Of course, for those with FH who have a serious need for a statin to reduce cholesterol, that a chewable, grape-flavored version of Lipitor is available in the EU is good news.
But if chewable Lipitor for kids gets approved in the US, who will make sure that Pfizer won’t repeat the marketing strategy that’s been so successful with adults? Who will make sure they don’t resort to scare tactics to convince people – parents of KIDS with high cholesterol — that Lipitor is indicated when it perhaps is not?
Let’s hope if chewable Lipitor ever arrives in the US (and if it stays in the EU) that it’s limited to those who really need it – those with FH. And that Pfizer will not look to profit on the backs of children who have high cholesterol but no other risk factors.
For more information on the risks and guidelines for cholesterol for children, see my recently published article on Answers.com, High Cholesterol in Children.