Should women who have paid for statins be given their money back?

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Cholesterol-reducing drugs known as statins are hugely popular and highly profitable. It’s a shame, then, that they aren’t very effective. I say this because while they have been shown to reduce the risk of cardiovascular events such as heart attacks, they do not reduce the overall risk of death when essentially healthy individuals are being treated. This was the conclusion of an analysis of 8 studies which had been performed using individuals with no previous diagnosis of cardiovascular disease [1]. This analysis also revealed that for one individual to be protected from a cardiovascular event (heart attack or stroke) over a 5-year period, 67 people would need to be treated.

Other evidence analysing the effectiveness of the national treatment guidelines in the USA, Canada, the UK and New Zealand has revealed the so-called ‘number needed to treat’ (NNT) varies from 108-198 [2]. These startlingly high NNTs have caused some to question whether statins are really the wonder drugs some would have us believe them to be.

But wait, it gets worse. Because the limited ‘benefits’ of statins seems to be confined mainly to men. The research has found that even in women with diagnosed cardiovascular disease and/or history of heart attack or stroke, statins do not reduce overall risk of death. And in healthy women, they don’t reduce the risk of cardiovascular events (heart attacks and strokes) either. The crashing failure of statins in women was fully elucidated in an analysis from British GP Malcolm Kendrick in the BMJ last year [3].

The singular failure of statin drugs to help women was highlighted this week in the British Medical Journal [4]. In a news piece, our attention was brought to an analysis from a professor of law and a professor of clinical epidemiology in the USA. The paper focuses on the most widely prescribed statin of all – atorvastatin (Lipitor) [5]. It looks at the evidence for the effectiveness of this drug in treating essentially women with no history of cardiovascular disease. In line with previous evidence on statins, there was no significant benefit to be found.

But the authors of this analysis go further by questioning the fact that when Lipitor is promoted and advertised, there’s plenty of talk about the fact that it reduces the risk of heart attacks, but no mention of it’s stunning lack of success with regard in women. They accuse Lipitor’s manufacturers of a lack of candour here, and also ask questions of the Food and Drug Administration (FDA) in the USA. At a bare minimum, they say, the FDA should be using its muscle to protect people against misleading marketing. They also suggest that women who have paid out of their pockets as a result of false promises should be compensated for the money they’ve effectively wasted.

The authors conclude: Our findings indicate that each year reasonably healthy women spend billions of dollars on drugs in the hope of preventing heart attacks but that scientific evidence supporting their hope does not exist.

According to the BMJ new piece, Pfizer have responded to the article in the form of a statement, which I can’t locate on the web. In this statement, Pfizer claims that “Cardiovascular disease is a major cause of death in women as well as men and it ultimately kills as many women as men. However, onset of disease is delayed by some 10-15 years in women compared to men; thus the National Institutes for Health (NIH) ATP III guidelines define age as a risk factor in women at age 55, compared to age 45 for men. In addition, the AHA CVD Guidelines for Women were updated in 2007 and recommend that healthcare professionals should focus on women’s lifetime heart disease risk, not just short-term risk.”

Let this not distract us from the fact, I say, that statins have not been shown to benefit essentially healthy women. And let’s not forget either that for each person that benefits from taking statins, many, many others don’t.


1. Abramson J, Wright JM. Are lipid-lowering guidelines evidence-based? Lancet 2007;369:168-169

2. Manuel DG, et al. Effectiveness and efficiency of different guidelines on statin treatment for preventing deaths from coronary heart disease: modeling study. BMJ 2006;332:1419

3. Kenrick M. Should women be offered cholesterol lowering drugs to prevent cardiovascular disease? No. BMJ 2007;334:983

4. Dobson R. Atorvastatin advertising misled over benefits for women, study claims. BMJ 2008;337:a2209

5. Eisenberg T, et al. Statins and Adverse Cardiovascular Events in Moderate-Risk Females: A Statistical and Legal Analysis with Implications for FDA Preemption Claims. Journal of Empirical Legal Studies. Published Online: Sep 5 2008

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