It's only fair to share…

Approval has been granted for the use of statin medications, which are used to lower cholesterol, by people who do not have high cholesterol. This is based on the rationale of preventing cardiovascular events such as heart attacks. A similar use was approved in the USA in 2010. The decisions are based on one study, the conduct of which has been seriously questioned.

Statins have been one of the most profitable drugs with billions (current estimates $26 billion USD) in sales annually for most of the last two decades. Each time the threshold of what constitutes “high” cholesterol has been lowered a whole new market has opened up. This latest extension takes us into even newer territory.

Unsurprisingly the supporters of this claimed the move will “save lives”. This is a great line to use when plugging any medical intervention as it sounds so wonderful and gives everyone a warm fuzzy feeling.

Time to be less warm and less fuzzy and dare I say – highly suspicious.

I hate to be party pooper but a major meta analysis through the Cochrane collaboration of over 65000 people through 11 studies showed no effect on all cause mortality (death) in people at “high risk” of cardiovascular (heart) disease but who had not had heart disease. It had no benefit in what is called primary prevention. In other words “treating “people who had high cholesterol with statin medication may lower their cholesterol but does not affect their overall health.

So on what possible basis you might wonder can we justify the use of cholesterol lowering drugs in people who do not have high cholesterol? The beauty of so called “evidence based medicine” with scientific trials by the tens of thousands is that you can always find one to back you up. And that will be the one used.

In the USA submissions to the FDA require the companies to submit two positive studies. If there are 200 negative ones it doesn’t matter, as they do not have to be submitted. The situation is not dissimilar in Australia.

This brings us to the JUPITER study. It reported a substantial decrease in risk of cardiovascular disease in people without existing heart disease or even raised cholesterol. The results were widely publicized. Nine other trials in the previous six years showed no benefit.

Yet a serious review of the trial published in the Archives of Internal Medicine found major flaws in the study. There was an unusually low rate of heart attacks and deaths-well below usually reported figures. The trial was discontinued after two years with no difference between the “treatment” and control groups on the most objective criteria.  The JUPITER trial excluded people with diabetes and high blood pressure.

The reviewers noted that “the possibility of bias entered the trial is particularly concerning because of the strong commercial interest in the study”. They concluded, “The results of the trial do not support the use of statin treatment for primary prevention of cardiovascular disease and raise troubling questions concerning the role of commercial sponsors”.

So much for saving lives!  The trial was well publicized and has been influential as a result of this. The pharmaceutical companies have done their best to ensure every doctor heard about it. The fact that the results contradict every other trial and do not match the conclusion of a large meta analysis across numerous trials can be ignored.

The JUPITER trial was published in 2008 but is still going strong. Recently I was invited to a dinner (low cholesterol food no doubt) to hear a cardiologist talk about the JUPITER study. I had a choice of two nights. Given the speaker is from interstate it is likely the talk will be repeated around Australia. The RSVP number was an interstate one too. The professor is what is described as an “opinion leader”. These doctors are seen as a key part of marketing by the pharmaceutical industry as doctors see them as colleagues rather than sales people. No prizes for guessing who is sponsoring the event.

Cholesterol has been demonized and is far less of a problem than it has been made out to be. This story is unraveling. Hence the trend is now to promote cholesterol-lowering medications as being helpful for heart disease regardless of cholesterol levels. Long-term use of statin medications is also not without side effects including muscle and liver damage. And we haven’t even mentioned the cost to individuals and government.

Companies have a right to promote their products. However there needs to be clearer lines between “research” and marketing. The public also has a right to know the extent to which the pharmaceutical tail wags the medical dog.