Chewable Lipitor for kids in Europe

Chewable Lipitor. Can you imagine? Should kids be taking statins? As our nation faces an obesity epidemic, we're seeing all types of lipid disorders in children and young people are dying from heart disease. Some kids have genetic conditions that predispose them to hypercholesterolemia, so it's really not based on their diet or exercise patterns. But for the rest of the kids out there who are living with elevated cholesterol levels, should they be taking a chewable statin so that they don't have a heart attack or a stroke as a teenager?

The European Union recently approved a chewable form of Lipitor for kids.

Soon, kids at school will need to pull out their pill boxes at lunch time. Let's hope they don't trade their pills like their lunch box snacks.  I wonder what the television commercials will be like if we see direct-to-consumer ads for chewable pediatric Lipitor someday.

FDA panel backs new use for AstraZeneca's Crestor

FDA panel backs new use for AstraZeneca's Crestor

12/15/2009, 5:56 p.m. EST

By MATTHEW PERRONE (AP)

GAITHERSBURG, Md. — Federal health advisers said Tuesday that expanded use of AstraZeneca's cholesterol pill Crestor can benefit patients with healthy cholesterol levels by preventing heart attack, stroke and death.
A Food and Drug Administration panel of experts voted 12-4 with one abstention that Crestor's benefits outweigh its risks in patients with normal cholesterol and no history of heart disease, setting the stage for a dramatic expansion of a drug that is already a blockbuster.
The FDA is not required to follow the group's advice, though it usually does. A decision is expected in the first quarter of next year.

(read more...)

Misguided health article on CNN about CRP

CNN has a story that has a misguided title (in my opinion). The story is titled, "Study suggests C-reactive protein doesn't cause heart disease." If we focus on causality, we may be missing the boat.

C-reactive protein (CRP) may not cause heart disease, but it may be a marker of underlying inflammation. Chronic inflammation may lead to coronary heart disease (CHD). If that's all true, then the title of the story can be misguiding. We often think in terms of cause and effect. If you have blood stasis (not moving), then you can form a blood clot. Cause and effect. So, if cardiovascular inflammation causes CHD, can you have inflammation without an elevation in CRP? Can you also develop CHD without any inflammation if you also have really high cholesterol levels? I think we're learning that the pathophysiology of CHD is not as simple as we learned about in medical school.

Well, if CRP doesn't cause heart disease, so what? What if CRP is an indicator of heart disease? That's the real question. It may not have a causal relationship, but that statement may be misguiding.

The JUPITER study published in the New England Journal of Medicine (NEJM) showed that a cholesterol-lowering drug Crestor (rosuvastatin) significantly reduced the incidence of major cardiovascular events in healthy-appearing patients who had low and normal cholesterol levels. This was such a groundbreaking study that it stirred significant controversy about CRP and the high-sensitivity CRP (hs-CRP).

CNN quotes the lead author of the JUPITER study in this story as "Another leading CRP researcher who isn't so sure about the findings published in the Journal of the American Medical Association (JAMA)." Dr. Paul M. Ridker, the director of the Center for Cardiovascular Disease Prevention at Brigham and Women's Hospital, in Boston, Massachusetts, said: "A null Mendelian randomization may not mean very much... While it does not support causality, I don't think most genetic statisticians believe it excludes a causal pathway either."

Are you familiar with Mendelian Randomization and Genetic Association Studies? Good, me too. The JAMA studied used this as one of its steps: " A mendelian randomization study for the most associated single-nucleotide polymorphism (SNP) in the CRP locus in our data together with published data on CRP variants with CHD let us assess the potential causal association of CRP with CHD." Did you catch all that? Good, me too.

Dr. Ridker argues that clinicians should still measure hs-CRP for the following reasons:

• A, it predicts vascular risk even when cholesterol is low and other risk factors are absent, and,
  
• B, because we have clinical trial data demonstrating that if you have an increased level of [hs-CRP], you will live longer and have fewer heart attacks and strokes if you take a statin.

Dr. Ridker goes on to say: "I have always felt that CRP is a good clinical biomarker of inflammation (and high vascular risk) but that it is inflammation that is likely to be causal for atherosclerosis, not CRP itself." To read the CNN story, click here.

Pfizer Offers Free Drugs to Unemployed, Uninsured

These are tough economic times and we need better patient assistance programs. Pfizer is coming out with a program to help people who have lost their jobs and health insurance. If you lost your jobs since Jan. 1 and you've been taking a Pfizer drug for three months or more, then probably qualify. These individuals will have access to free prescription Pfizer medications (including common drugs like Lipitor which is used to lower cholesterol and Viagra for the treatment of erectile dysfunction) for up to a year.

• Starting today, patients can call a toll-free number, 866-706-2400, to sign up.
• Starting July 1, patients can also apply through the Web site

So, do you know anyone who could take advantage of this program?