April 1, 2012

Heart disease vaccine?

Prime News tonight (I don’t see how to link to an individual story there) reported on a ‘vaccine for heart disease’.  This is really exciting research from the Karolinska Insitute in Sweden, studying the role of the immune system in coronary artery plaque.  The previous belief was that damaged (oxidised) LDL cholesterol, which is a consequence of plaque, triggered the immune responses; the researchers showed that the immune response was to normal LDL cholesterol.  They also showed that a vaccine blocking the immune response led to reduction of white blood cell involvement and shrinkage of plaques in transgenic mice.

Prime News went on to say that a vaccine might be available within five years.  I hope this isn’t realistic. The initial human studies to show an effect on plaque could easily be done in that time, but not a trial that actually demonstrates reductions in heart attack rates.

There is lots of depressing experience in cardiovascular research with good ideas for treatments that affect a biological measurement related to heart disease, but don’t actually reduce the risk of heart attack or death, because something goes wrong.   The US FDA, who will be the primary group that researchers have in mind when designing trials, is fairly insistent on having actual evidence of clinical benefit from new treatments.  Their Cardiovascular & Renal advisory committee is one of the most tough-minded, ever since it relied on mere biological surrogates of benefit to make what was probably the worst drug approval decision in history: approving drugs to regulate heart rhythm without evidence that they actually prevented cardiac arrest.  They didn’t.



Thomas Lumley (@tslumley) is Professor of Biostatistics at the University of Auckland. His research interests include semiparametric models, survey sampling, statistical computing, foundations of statistics, and whatever methodological problems his medical collaborators come up with. He also blogs at Biased and Inefficient See all posts by Thomas Lumley »